MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PRIVATE LABEL; SOLUTIONS

Model Number 09424X

Device Problems Device Emits Odor (1425); Device Markings/Labelling Problem (2911)

Patient Problems Conjunctivitis (1784); Keratitis (1944); Pain (1994); Swelling (2091); Burning Sensation (2146); Excessive Tear Production (2235); Deformity/ Disfigurement (2360); Caustic/Chemical Burns (2549)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

A patient called to report that she purchased a 3x16 pack of multi-purpose solution from a retailer with lot: aa04314, expiration 1/2017, (lot on box) in 2015, and didn''t use the product until 2017.Three bottles were in the box and had the tamper evident shrink seal around the caps.The patient is unsure as to whether or not the box was sealed at time of purchase.One bottle she used completely with no issues and discarded it, the second bottle the lot number on the box and bottle matched (bottle opened, but not used), the third bottle (complaint bottle) the lot number on the bottle and box did not match.Lot number on complaint bottle was ap01018 expiration: 5/2016 lot on box was aa04314 expiration 1/2017.The patient said she used the complaint bottle of solution on (b)(6) 2017 to clean and disinfect her lenses.The next day, (b)(6) 2017 she removed her lenses from the lens case, put them in her eyes, and her eyes burned immediately.She flushed her eyes at home with water for about 15 minutes, then started to experience fogging in her vision.Patient then went to the emergency room.In the emergency room the doctor put numbing drops then did vision tests, one test was to read letters on the vision chart then the doctor looked at her eyes with a scope type device and said she had chemical keratitis, doctor then smelled her solution bottle and said it smelled very strong.The doctor gave her antibiotic drops -vigamox - 1 drop every 2 hours while awake.Doctor also told her to use ibuprofen and gave her a prescription for a strong narcotic pain pill, she didn't take it.Patient saw her ophthalmologist, who said her eyes were doing better, but there was still a little bit of swelling.Doctor told her to stop using the antibiotic drops and use lubricant drops, like visine.Doctor told her that she is stopping the antibiotic drops because her eyes are healing on their own.Patient said before she used the bottle she did smell an odor that smelled like bleach, but she thought it was the bathroom cleaning stuff that lingered from cleaning earlier (2 days earlier), it didn''t dawn on her that it could be the contact lens cleaner.Bottle and solution in lens case both smelled like bleach.

Manufacturer Narrative

Corrected data: in the initial mdr, should have indicated that initially, the patient's spouse reported the event and then in follow up, the patient provided the additional details.Type of report: alternative report identification number (b)(4).Device evaluation: the product was identified as expired; therefore, no product testing was performed.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.Reported lot was manufactured in may 2014, expiration date was may 2016.The records for production process were found to be acceptable, all testing items were completed and met specifications, including incoming chemical materials testing, primary materials inspection, product physical appearance inspection, bulk and finished product chemical testing and microbial testing, sterilization records, environment monitoring and water system monitoring.There were no non-conformances related to this complaint.In conclusion, reported lot was deemed acceptable for release.Labeling evaluation: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

In the mdr follow up (supplement) #1, a conclusion code of misuse should have been entered and was inadvertently not included in the report.The following has been updated accordingly.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Additional information: age/date of birth: on (b)(6) 1974.The following additional information was received; the incident caused the patient to suffer an acute chemical burn to her right eye, with associated pain and impaired vision, along with significant psychological trauma.Patient was diagnosed with chemical keratitis and keratoconjunctivities, caused by exposure to a bleach-like substance in her contact lens solution.The pain, burning, irritation, redness, and feelings of heaviness and discomfort in the eyes lasted for an extended period of time following the exposure.Patient was unable to wear contact lenses while the swelling and irritation persisted, and was afraid to begin wearing them again even when able, due to the trauma associated with the incident.Among other psychological effects of the intense pain, panic, and fear of going blind associated with the incident, patient has subsequently experienced nervousness and anxiety when applying eye drops and using other medical or cosmetic products.Medical treatment: on examination at the emergency room, the doctor noted patient was positive for pain and visual disturbance in the eye.Noted right conjunctiva was ''markedly'' injected (red/bloodshot) but not bleeding.Upon slit lamp examination, doctor noted the right eye shows corneal abrasion with punctate fluorescein uptake, consistent with keratitis of the cornea.Noted that there was no concern for patient's pre-existing glaucoma causing the pain, intraocular pressures were normal.Patient diagnosed with an acute chemical burn of the right eye, treated with morgan lens irrigation with a large volume of fluid to flush any residual chemical solution for the eye.The procedure, necessary to prevent any further damage to her eye, caused patient to suffer from increased pain and burning, doctor administered proparacaine anesthetic eye drops.Prescribed antibiotics (moxifloxacin) eye drops every two hours, was well as hyrdrocodone with acetaminophen and ibuprofen for pain.No focal ulcer was found but a generalized keratitis is present.Follow up with an ophthalmologist was indicated along with home care instructions for chemical burns to the eye.The patient went to her follow up exam as directed on (b)(6) 2017.The doctor noted that the patient had been compliant in her used of antibiotic eye drops as prescribed at the emergency room visit.Doctor dilated the patient's eyes and diagnosed keratoconjunctivitis of the right eye.Patient was additionally prescribed preservative-free artificial tears and warm compresses.Doctor reported that the contact lens solution bottle clearly contained chlorine bleach.On (b)(6) 2017, at a follow up appointment, for continued soreness and swelling of the right eye.Doctor advised patient to continue with artificial tears and warm compresses and see if the discomfort improved over time.It was noted that with diligent care, given the patient is a registered nurse, the pain and discomfort eventually largely dissolved.At present, patient had only slight residual redness and irritation.Patient was seen on (b)(6) 2017.Patient stated she is feeling heaviness and tiredness at the end of the day on the affected side and requested her eye be checked again.Patient reported using visine tears now.Visual acuity was 20/15 for both eyes.Intraocular pressure was 14mmhg in both eyes.Keratoconjunctivitis, right eye chemical resolved.Additional patient codes: 2330, 2038, 1941.Alternative reporting number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review of the mdrs submitted, it was realized that although additional information regarding patient symptoms were provided in follow-up #3, some patient codes were inadvertently not captured within section h6, patient codes.The following patient codes are now provided: section h6: patient code: 1789 corneal abrasion; section h6: patient code: 2138 vision impaired; section h6: patient code: 2328 anxiety; section h6: patient code: 2329 distress; section h6: patient code: 2137 blurred vision.Section g7: alternative report number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text: placeholder.

Manufacturer Narrative

Corrected data: additional information was received via legal documents.It was learned that although initially, the consumer reported that the third bottle of three bottles of solution was the complaint bottle, the reported issue occurred with the second bottle, lot ap01018.The lot number remains the same as previously reported.Additional info.Section h6: based on the additional information received that the consumer also experienced sobbing and physical disfigurement.Therefore, the following patient codes have been added: 2235, 2360.Section g7: alternative report identification number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: PRIVATE LABEL
• Type of Device: SOLUTIONS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6532086
• MDR Text Key: 74005954
• Report Number: 3004537773-2017-00001
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 00827444000317
• UDI-Public: (01)00827444000317(17)160531(10)AP01018
• Combination Product (y/n): Y
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/01/2005,10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 09424X
• Device Lot Number: AP01018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR