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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LLC OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Catalog Number 0065035720
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Irritation (1941); Keratitis (1944); Pain (1994); Swelling (2091)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.(b)(4).
 
Event Description
As initially reported by her attorney on 24apr2018, the female consumer bought the contact lens solution last (b)(6) 2017, and had experienced irritation and eye sore.Her right eye became worse than the left making her decide to seek medical attention.It was then determined that she had a microbial keratitis which developed into a corneal ulcer.Pain became very severe and the consumer had undergone surgery to remove the right eye on (b)(6) 2017.The treatment regimen, surgical procedure as well as the patient's current status was not made known.Additional details may be limited depending on the documents forwarded by legal department, however further details are still requested but has not been received.As of 14may2018, no further details currently provided.
 
Manufacturer Narrative
New information received.The manufacturer internal reference number is: (b)(4).
 
Event Description
As of (b)(6) 2018, additional information confirmed that the consumer was not made aware of important warnings since the instructions were found on the inside of the carton and not as a package insert included in the product.The attorney believed that this had led to the consumer's injury.Further details cannot be obtained as this is being handled by legal department.
 
Event Description
As of 18jun2019, medical records were received from legal department.It was indicated that the consumer was able to visit her ecp for consultation last (b)(6) 2017 because of pain on her right eye.On (b)(6) 2017, she was then diagnosed with central corneal ulcer on the right eye.On her first consultation last (b)(6) 2017, it was documented that the consumer was allergic to mushrooms causing an anaphylactic reaction when taking it.She was also allergic to medications such as tramadol which caused seizures, zinc acetate which caused an anaphylactic reaction, salbutamol which caused her to vomit and felt like her veins were on fire, oxycodone 10-325 mg which caused like her blood was on fire, cephalexin which made her feel sick and adhesive tape which caused rashes.It was also indicated that the consumer was taking medications prior to the event which started on (b)(6) 2017.She was taking bupropion sr 150 mg twelve hour sustained released tablet to be taken one tablet by mouth twice a day.On (b)(6) 2017, she started taking citalopram 40 mg taken one tablet by mouth every day.On (b)(6) 2017, she was given glimepiride 2mg to be taken one tablet by mouth twice a day.On (b)(6) 2017, she took metformin xr 500 mg twenty four hour sustained release tablet to be taken two tablets by mouth twice daily.On (b)(6) 2017, the consumer was prescribed with pravastatin 40 mg to be taken one tablet by mouth every day.On (b)(6) 2017, the consumer was prescribed with ranitidine 150 mg to be taken one tablet by mouth twice a day.On (b)(6) 2017, she took verapamil 120 mg to be taken one tablet by mouth twice a day.On (b)(6) 2017, the consumer was prescribed with amitriptyline 25 mg to be taken three tablets by mouth at bedtime which was discontinued on (b)(6) 2017.On (b)(6) 2017, she also took cyclopentolate 1% solution to be instilled one drop into her right eye three times daily which was discontinued on (b)(6) 2017.On (b)(6) 2017, the consumer was given freestyle lite test strip to test blood sugar two times per day which was discontinued on (b)(6) 2017.On (b)(6) 2017, she took ibuprofen 800 mg to be taken one tablet by mouth every eight hours as needed for pain which was discontinued upon discharge on (b)(6) 2017.On (b)(6) 2017, she was took lantus solostar 100 unit/ml solution pen injector to be injected fifty eight units subcutaneously every day which was discontinued on (b)(6) 2017.On (b)(6) 2017, she took ofloxacin 0.3% ophthalmic solution placed one drop in both eyes three times a day which was discontinued on (b)(6) 2017.On (b)(6) 2017, she took polymyxin b-trimethoprim 10000-0.1 unit/ml -% ophthalmic solution to be applied one drop into both eyes four times a day which was discontinued on (b)(6) 2017.On (b)(6) 2017, she took prednisolone 1% ophthalmic suspension instilled one drop into her right eye one to two times a day which was discontinued on (b)(6) 2017.On (b)(6) 2017, she was also given vancomycin 25 mg/ml eye drops compound placed one drop into the right eye every hour while awake for 10 ml which was discontinued on (b)(6) 2017.On (b)(6) 2017, she was given hydrocodone-acetaminophen 10-325 mg tablet to be taken by mouth every four hours as needed for pain for 45 tablets and was discontinued on (b)(6) 2017.On (b)(6) 2017, she took tobramycin 15 mg/ml eye drops compound to be placed one drop into the right eye every hour while awake, this is for 6.425 ml and was discontinued on (b)(6) 2017.Other medications that were reported and has been discontinued by another clinician were acetaminophen 300-30mg tablet, gabapentin 300mg capsule, fluconazole 200mg tablet, prednisone 20mg tablet, erythromycin 5mg/g ophthalmic ointment.The ecp noted that the consumer had a corneal ulcer with infiltrate and anterior chamber involvement in her right eye but the vitreous was clear on external ultrasound.Her pain score was 7/10.The consumer also had undergone b-scan ultrasound which had revealed no mass lesions of the globe or orbit.The vitreous appeared clear and the retina appeared attached.Immersion scan was also performed to visualize the anterior segment and there was marked corneal thickening.The consumer was advised to return for another medical visit on (b)(6) 2017.She was advised to quit using tobacco or cigarettes.On her next visit last (b)(6) 2017, the consumer was seen by her ecp.The consumer expressed severe distress due to the large central corneal ulcer on her right eye causing severe pain.She had also noted the desire to improve the situation like eye rehabilitation.The ecp noted that there was an unknown bacterial infection and in doubt whether it was fungal, parasitic or viral.The consumer was advised to restart cyclopentolate three times a day on her right eye.Pain management was advised with fortified antibiotics such as vancomycin or tobramycin every one to two hours while awake for eight doses per day.The consumer was advised to discontinue all other drops.The consumer was also prescribed to increase hydrocodone-acetaminophen from 5/325 to 10/325.She was advised to continue ibuprofen 800mg three times daily and emphasized hydration.The ecp indicated that the consumer would most likely undergo penetrating keratoplasty on her right eye within the next two weeks so medications would need adjustments to stabilize the cornea in preparation for the transplant.Symptoms of perforation was discussed and consumer was advised to use eye shield 24/7 and avoid eye rubbing.On (b)(6) 2017, the consumer visited her ecp.It was noted that the events were no worse, stable and the pain is a little better.The ecp noted that the eye still looks like it has a bacterial infection and will leave bandage contact lens on for now.The consumer expressed that pain is a little more manageable with the bandage contact lens in place.The consumer was scheduled for a primary care appointment on tuesday.She was a soft contact lens wearer when the problem started and had bilateral keratitis on both eyes.The left eye rapidly resolved by using antibiotics but the right eye was smoldering for three months.The consumer had some initial response to antifungal drops but stopped working after five days and got worse.The consumer was advised to use only cyclopentolate three times daily.The ecp had reviewed symptoms of perforation and discussed possible conjunctival flap, tars or therapeutic penetrating keratoplasty in the next seven to fourteen days.On (b)(6) 2017, consumer visited her ecp.It was indicated that the event appears to be bacterial but no culture was done before starting antibiotics.The consumer was advised to continue cyclopentolate three times a day, tobramycin and vancomycin every hour.She was also advised to start prednisolone three times a day.Therapeutic penetrating keratoplasty may be needed in the next one to two weeks.On (b)(6) 2017, the consumer visited her ecp and had undergone aerobic eye culture and gram stain using swab technique on her right cornea with negative results, no growth, no organisms seen and no polymorphonuclear leukocytes seen.It was also indicated that the consumer was non-compliant to her medications.Ecp discussed need for continued aggressive care.She was advised to continue cyclopentolate three times a day, tobramycin and vancomycin every hour, and discontinue prednisolone three times a day.Follow up visit was scheduled on tuesday 8:00am.The consumer was scheduled for corneal transplant surgery on wednesday (b)(6) 2017.The consumer was also scheduled for corneal biopsy and culture, and a possible conjunctival flap.On (b)(6) 2017, at around 09:42 the consumer was in the emergency department with corneal ulcer on her right eye presenting an intractable pain.Consumer was scheduled for surgery, however pain had increased.According to the consumer¿s ecp the consumer needs to be consulted to pain management and shall be admitted to control the pain.At 11:32, triage and assessment was completed.The consumer was changed into her hospital gown and was placed on monitor.Vital signs were noted as stable.Her attending ecp were at bedside for initial assessment.The consumer updated on plan and verbalized understanding.At 13:06, pain medication was given.The consumer was resting in bed.Lights dimmed for comfort.Family were at bedside and side rails up.At 13:10, consumer was resting in bed and vitals were stable.At 13:16, blue top redrawn and sent.The consumer had tolerated well and was requesting pain medications.At 13:40, pain medications were given.The consumer was updated on plan and verbalized understanding.At 14:27, lab at bedside to draw third blue top.At 14:35, consumer was resting in bed and was requesting more pain medication.Her ecp contacted pain service and her eye specialist discussed eye drops.At 15:45, the consumer appeared to be sleeping, respirations even and unlabored.At 16:26, eye specialist was at her bedside.At 16:59, consumer was resting with friend at bedside.Vitals were assessed and stated her eye is in extreme pain.The consumer had requested pain medications.At 17:14, pain medications were given.The consumer was ambulated to restroom with steady gait.At 17:29, consumer stated that she is having a panic attack.The consumer's respirations is 16, spo2 100%, lungs sounds clear bilaterally.The consumer was moved to sitting position.Ecp was at bedside.At 17:52, attending ecp was at bedside.At 20:49, consumer was resting comfortably in bed.No additional needs at this time.At 23:14, consumer appears to be sleeping comfortably.The consumer had good response to low dose ketamine hydrochloride and fentanyl and then to fentanyl alone.Her current pain regimen was hydrocodone-acetaminophen 10 mg every four to six hours and ibuprofen 800mg every eight hours.Plan was to discontinue with new regimen of hydromorphone 2mg every six hours, acetaminophen 650 mg every eight hours, and ibuprofen 800 mg every eight hours.She was given hydromorphone 2mg by mouth, acetaminophen 1 gram by mouth, and ketorolac tromethamine 30 mg intramuscular in the emergency department with good effect.Patient very nervous about being sent home and had panic attack that resolved with coaching.The consumer¿s current discharge medication includes acetaminophen 650 mg controlled release tablet to be taken one tablet by mouth every eight hours as needed for pain quantity thirty tablets, hydromorphone 2mg tablet taken one tablet by mouth every four hours as needed for pain, quantity thirty tablets.On (b)(6) 2017, around 01:09 the consumer appears to be resting comfortably.At 02:10, consumer remained asleep at this time.At 03:40, consumer remained asleep.At 06:04, consumer was awake with pain.She did not require pain medication for the majority of the night.Applied eye drops and medicated for pain.No additional needs at this time.At 07:19, report was endorsed to the next health care professional.At 07:23, consumer was resting in bed, continuous positive airway pressure in place with oxygen saturation, the consumer does not appear to be in acute distress.At around 09:55, consumer was in visible distress and moaning in pain, restlessness, guarding the affected area, as well as tearful.Pain medication administered as ordered.At 13:41, endorsed to the next health care professional.The consumer's eye drops were on bed with ice.Review of systems done and are negative.At 2:04 am, consumer was sleeping at this time and pain has been well controlled on new regimen.At around 7:48 am, consumer was resting in bed in and reported her eye pain has returned but was well controlled with pain medications last night.At 1:00 pm, ecp consulting with re-examination of consumer and recommend admission for continue antibiotic therapy and further pain control.In her history of present illness, it was stated that she developed right eye pain several months ago and claimed that her contacts must have been contaminated.She also reported "stabbing" pain centralized around the right eye with associated intermittent yellow colored discharge.She is unable to see out of the eye, and added that she only sees "light and dark." her pain radiates into her head and reports associated photophobia and nausea.No recent fever or chills.The consumer was also given ondansetron for nausea.The consumer's corneal ulcer represents a threat to bodily function.The consumers was given a non-invasive ventilation equipment called continuous positive airway pressure.The consumer was receiving a heated humidification.The consumer declined spiritual care.Duoderm extra thin dressing was also placed on bridge of consumer's nose.As of (b)(6) 2017, day three of hospitalization and her vitals were normal, the consumer's pain was controlled with erythematous conjunctiva, an obvious discharge and right corneal ulcer 1cm.The consumer was given enoxaparin for deep venous thrombosis prophylaxis.Consumer was able to open eye better and was scheduled for operation on (b)(6) 2017.As of (b)(6) 2017, the consumer's vital sign were normal and continuous positive airway pressure was still in place.The consumer continued to report pain in the right eye and added visual hallucinations, which she subjectively described as "seeing a little man" on the bed.She was compliant to her hourly eye drops but requested to decrease nicoderm patch.The consumer continued to report photophobia and nausea.Her gross intake for the past 24 hours was 1997 ml.The consumer's current administered medications included amitriptyline tablet 50 mg every morning, dextrose 50 % solution 12.5 g as needed, glimepiride tablet 2mg twice a day with meals, insulin lispro injection before meals and at bedtime, metformin xr 24 hour sustained release tablet 1,000 mg twice a day with meals, acetaminophen tablet 975 mg every eight hours, enoxaparin syringe 40 mg every 24 hours, hydromorphone tablet 8 mg every four hours as needed, nicotine patch 14 mg/24hr one patch every twenty four hours, ondansetron tablet 4mg every six hours as needed, amitriptyline tablet 25mg every night at bedtime, bupropion sr 12 hr tablet 150 mg twice a day, citalopram tablet 40 mg daily, cyclopentolate 1 % ophthalmic solution 1 drop three times daily, ibuprofen tablet 800 mg every eight hours, insulin glargine injection 58 units every morning, pravastatin tablet 40 mg daily, ranitidine tablet 150mg twice a day, tobramycin 15 mg/ml eye drops an gentle lubricant eye 10 ml every hour while awake, vancomycin 25mg/ml eye drops and gentle lubricant eye 10 ml every hour while awake, verapamil tablet 120 mg two times per day.Other medications for type ii diabetes which the consumer needed to continue was insulin lispro sliding scale of 0-16u as needed.The consumer's nicotine patch was decreased to dose of seven as preferred.Electrocardiogram qtc to be monitored.The consumer experienced constipation with no bowel movement for 3 days in setting of hydromorphone usage.The consumer was prescribed with polyethylene glycol 3350 as needed for constipation, docusate sodium twice a day.The consumer is on continued diabetic diet.According to ophthalmology consultation consumer noticed some itching and watering on her left eye, her pain was controlled but felt nauseated.As of (b)(6) 2017, the consumer continues to experienced nausea and she noted some white, purulent discharge from the right eye.The consumer's continuous positive airway pressure was discontinued.According to the consumer's physical therapist, her pain score was 4/10.The consumer was on bedrest with bathroom privileges.The consumer was still noted as having vision deficit.Her overall cognitive status was within functional limits.The consumers bed mobility, transfers, gait and stairs was stand by assistance.Her gait was limited to bathroom per order and she was still sensitive to light.The consumer's mobility and balance were at usual speed with supervision and minimal assist.She was a little able to stand from a chair, walk in a hospital room, and climb three to five steps with rails.Her mobility score was 21 with cms of 28.97.The consumer had ambulation deficits, balance deficits and decreased endurance.Her activities were limited to bed rest with bath room privileges and light sensitivity.The consumer was for balance training, bed mobility training, transfer, stairs and gait training three to four times a week and as needed during admission.The consumer was ordered nothing by mouth at midnight.As of (b)(6) 2017, the consumer's overall cognitive status was within functional limits and independent with her bed mobility and transfers.The consumer's basic vital signs were normal and her intake within the last 24 hours was 585 ml.The consumer was to start new medications like magnesium hydroxide 400mg/5ml suspension 30 ml daily as needed, polyethylene glycol packet 17gram daily, trimethobenzamide capsule 300mg every eight hours as needed and sennosides-docusate sodium 8.6-50mg 2 tablet twice a day.The consumer was scheduled for surgery at 15:00.She was monitored for acute worsening in pain or marked vision changed at risk for rupture.The consumer's pain was controlled to 5/10 and nausea had improved.The consumer was evaluated and perforation on the eye already occurred with placed contact, no active drainage.The consumer was able to see light out of the right eye and has noticed border of ulcer.She expressed anxiety about discharge home plans and being able to control pain.Bandage contact lens was placed for comfort and continue to consider surgical management with 3/4 conjunctival flap with partial tarsorrhaphy.Vital signs were noted as follows, at 00:54, blood pressure 142/91, pulse 84, temperature 36.7c (98.1f), respiratory rate 18, sp02 93%.At 05:12, blood pressure 117/58, pulse 87, temperature 36.1 c (97f), respiratory rate 18, sp02 96%.At 09:30, blood pressure 134/70, pulse 36 c (96.8 f), respiratory rate 20, sp02 88%.At 12:52, blood pressure 131/79, pulse 91, temperature 36.9 c (98.5f), respiratory rate 16, sp02 90%.The consumer was oriented to person, place, and time.She appeared well-developed and well-nourished but in distressed.Other medications included acetaminophen 650mg controlled release tablet to be taken one tablet by mouth every eight hours as needed when in pain for thirty tablets, hydromorphone 2mg tablet to be taken one tablet by mouth every four hours as needed when in pain for thirty tablets, amitriptyline 25 mg tablet to be taken 75 mg by mouth at bedtime, cinnamon 500 mg tablet to be taken 500 mg by mouth daily, cyanocobalamin (vitamin b-12) 1000 mcg tablet to be taken 1,000 mcg by mouth daily, insulin glargine 100 unit/ml injection to be injected 50 units subcutaneously at bedtime, cyclopentolate 1 % solution to be instilled one drop into the right eye three times daily for a quantity of 5ml and two refills, tobramycin 15 mg/ml eye drops compound t be placed one drop into the right eye every hour while awake with a quantity of 6.425 ml, vancomycin 25 mg/ml eye drops compound one drop every hour while awake with a quantity of 10 ml and one refill, bupropion sr 150 mg twelve hour sustained release tablet to be taken one tablet by mouth twice a day, citalopram 40 mg tablet to be taken one tablet by mouth every day, glimepiride 2 mg tablet to be taken one tablet by mouth twice a day, ibuprofen 800mg tablet to be taken one tablet by mouth every eight hours as needed for pain, metformin xr 500 mg 24 hour sustained release tablet to be taken two tablets by mouth twice daily, pravastatin 40 mg tablet to be taken one tablet by mouth every day, ranitidine 150 mg tablet to be taken one tablet by mouth twice a day, and verapamil 120 mg tablet to be taken one tablet by mouth twice a day.The consumer's current regimen of ibuprofen and oxycodone was not working.The consumer was to be discharged on trial of hydromorphone, acetaminophen and ibuprofen, but was extremely anxious about being discharged and getting adequate pain control.Plan is for trial of these medications overnight and if helping discharge on that regimen.If consumer not improving reconsult with ecp.The consumer was on antibiotics eye drops that need to be administered every one hour while awake.As of (b)(6) 2017, the consumer continued to use oxygen at home with 3l/minute flow.She reported continued deeper pain on 6/10 scale and photophobia.She also stated that when she woke up this morning, she wiped a large amount of white liquid/mucous from her right eye and bandage contact lens fell out of place, when she was "dabbing her eye." the consumer¿s activity status is up with assistance and surgical precautions for fall and social precautions of vision deficit.Her overall cognitive status was within functional limits.The consumer can stand with assistance with usual gait speed.Her vital signs were normal but the consumer reported no bowel movement.She was back on a diabetic diet as of 13:33.Bandage contact lens replaced for comfort, shield placed over eye for protection (to be removed for hourly drop administration).The consumer was to continue fortified vancomycin 25 mg/ml every hour to the right eye, fortified tobramycin 15 mg/ml every hour to the right eye, 5 minutes in between application of antibiotic drops, cyclopentolate three times a day to the right eye for cycloplegia.She was also planned for discharge when able for continued assistance with eye care and pain control to salvage right eye and prevent endophthalmitis and worsening infection and to consider surgical management with 3/4 conjunctival flap with partial tarsorrhaphy on (b)(6) 2017.As of (b)(6) 2017, follow up was done by ecp at 10 am to check if consumer complained of severely increased pain, marked changes in vision (currently seeing light perception only), or if there is concern for perforated cornea.There was no surgery performed during this admission.The consumer was prescribed to continue tobramycin drops every hour, vancomycin drops every hour, and cyclopentolate drops three times a day and wait five minutes in between drops.She was also advised to keep bandage contact lens in place.The consumer was scheduled for follow up visit on (b)(6) 2017.As of (b)(6) 2017, consumer revisited her ecp and was recommended for a patch graft.After discussing the risks benefits and alternatives of surgery, the consumer declined to proceed with the surgery.She stated pain was her main concern and would like to remove the eye.Told her that there may be visual potential in the right eye however she does not want to attempt further corneal surgery.The consumer was prescribed with clavulanate acid 500-125 mg to be taken one tablet by mouth three times daily for seven days.She was scheduled for corneal transplant on (b)(6) 2017.As of (b)(6) 2017, consumer was admitted for corneal perforation on the right eye and was scheduled for evisceration or removal of the right eye since she declined further corneal surgery.The surgery was carried out under general anesthesia.The procedures done were as follow, right evisceration, right posterior sclerotomy, right insertion of a 20-mm medpor implant and right temporary tarsorrhaphy.Once general anesthesia had been induced, retrobulbar injection was given with 2% lidocaine and epinephrine.The upper and lower lids were opened using a lid speculum, and a conjunctival peritomy was fashioned.The corneal button was removed and the contents of the eye were removed.Irrigation with antibiotics was carried out and posterior sclerotomy was fashioned 360 degrees around the globe.The extraocular muscles were not detached in this process.Scar tissue was released and 20-mm medpor implant was soaked and inserted into the scleral pocket where the sclera was closed using interrupted 6-0 vicryl sutures.The conjunctiva and tenon's were similarly closed with 6-0 vicryl sutures and a medium size conformer was placed in the eye.A temporary tarsorrhaphy with a 6-0 vicryl suture was applied.The consumer was taken to recovery room in excellent condition.The estimated blood loss was <10ml.The consumer was monitored and noted that she felt better than the past months.Medications administered were bupivacaine injection, cefazolin irrigation 1 gm/250 ml, erythromycin ophthalmic ointment, lactated ringers infusion, lidocaine 2 %-1:100000 injection, propofol 200 mg, remifentanil 400 mcg infusion, rocuronium injection, cefazolin injection, dexamethasone sodium phosphate injection, fentanyl 50 mcg/ml injection, lidocaine hcl 4 % injection, ondansetron injection, propofol, succinylcholine injection.It was also noted that the consumer had a history of oral surgery, carpal tunnel surgery and eye plastic surgery.An endotracheal tube was inserted at around 9:49 am.It was also noted that the consumer had a history of postoperative nausea and vomiting, chronic asthma, sleep apnea, dyspnea on exertion such as walking and gastroesophageal reflux disease.She was advised to remove the patch the next day and apply prescribed ointment three times a day to the inner corner of the right eye.The consumer was also given the permission to wash and take a bath.She was advised to take the oral antibiotics as prescribed and was scheduled for a follow up visit in six weeks.The consumer was educated about what to expect such as some degree of swelling, bruising and discharge of tears and blood-stained tears.Additional discharge instructions included bed rest after surgery, resume normal diet when ready, apply ice bag to relieve pain, avoid alcohol consumption and mobile driving, if vomiting occurs, bleeding and unable to urinate notify ecp immediately.As of (b)(6) 2017, consumer visited ecp for follow up.Ecp noted that the consumer was healing well and was okay for prosthesis.No further details available.
 
Manufacturer Narrative
The event classification field was updated to capture the events that weren't reported in the mdr last year.The actual complaint product was not returned for evaluation.No trend could be identified and the root cause could not be determined.No further investigation was done.Patient code 3191: no code available for photophobia, constipation, erythema of upper and lower eyelids, nervous/panic attack, hospitalization, some central thinning, corneal perforation of right eye.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON RESEARCH, LLC
6201 south freeway
fort worth TX 76134
MDR Report Key7535500
MDR Text Key108980741
Report Number1610287-2018-00018
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
PMA/PMN Number
K050729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2018
Device Catalogue Number0065035720
Device Lot Number258424F
Other Device ID NumberZ00000300650356107
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/24/2018
Initial Date FDA Received05/22/2018
Supplement Dates Manufacturer Received09/18/2018
06/18/2019
Supplement Dates FDA Received10/15/2018
07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMITRIPTYLINE; BUPROPION SR; CITALOPRAM; CYANOCOBALAMIN; ENOXAPARIN; GABAPENTIN; GLIMEPIRIDE; LANTUS SOLOSTAR; METFORMIN XR; ONDANSETRON; PRAVASTATIN; PREDNISONE; RANITIDINE; TRIMETHOBENZAMIDE; VERAPAMIL
Patient Outcome(s) Hospitalization; Disability;
Patient Age47 YR
Patient Weight113
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