MAUDE Adverse Event Report: ALCON RESEARCH, LLC AOSEPT PLUS/CLEAR CARE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 0065035820

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Pain (1994); Increased Sensitivity (2065); Fungal Infection (2419)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by consumer's family member via telephone on (b)(6) 2020, it was stated that the consumer used contact lens solution and was diagnosed with corneal ulcer in the right eye.Upon examination of the contact lens case and lenses by a corneal specialist, it was tested positive for fungus scedosporium.Consumer was recommended a 8 week treatment course.Additional information received on 01jun2020, stated the size of the corneal ulcer was 4*5mm and consumer has been enduring significant pain and photophobia for the past 5 weeks.Consumer had initially been treated on (b)(6) 2020 with gatifloxacin, fortified tobramycin, and fortified vancomycin every 1-2 hours around the clock.On (b)(6) 2020, natacyn was added, 1-2 hours around the clock.On (b)(6) 2020, voriconazole was added 1-2 hours around the clock.No medical intervention was required.Symptoms outcome are improving.Additional info has been requested but not yet available.

Event Description

Additional information was received on (b)(6) 2020, the consumer sent a patient impact statement which indicated that the consumer underwent a 3-month course of treatment for corneal ulcer.The consumer reported a decrease in the visual acuity from 20/20 to 20/30 and confirmed the location of the corneal ulcer to be at the upper part of the cornea.The consumer experienced decreased binocularity and degraded depth perception.The consumer received eye drops at every hour around the clock to get infection under control.Patient was scheduled with treatment protocols from (b)(6) 2020 to (b)(6) 2020 at 02am to 10pm daily, during this treatment course, patient was treated with antibiotics, antifungal and compound drugs.The treatment regime included moxifloxacin from (b)(6) 2020 to (b)(6) 2020, natacyn from (b)(6) 2020 to (b)(6) 2020 and voriconazole from (b)(6) 2020 to (b)(6) 2020.On (b)(6) 2020, corneal topography fo r both eyes was performed and placido imaging, mesopic eyes test was also evaluated.The wave front values for right eye compared to reference range indicated a difference of +0.25 (ref: +9.50; wf@4.32 : +9.75) in cylindrical power and 1 in axis (ref: 146; wf@4.32 : 147).Additional info has been requested but not yet available.

Manufacturer Narrative

Additional information has been updated in b.5., b.6., h.3., h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received on 20jul2020 states consumer has a moderate scar and severe irregular astigmatism post treatment of fungal ulcer that has resulted in reduced visual acuity.Further information has been requested.Awaiting response.

Manufacturer Narrative

A1,b5,: additional information has been updated.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: the complaint product was returned for evaluation and was found to meet manufacturing specifications.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: 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.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information of medical records received from physician on 14oct2020, which states that, on (b)(6) 2020, patient presented for evaluation of corneal ulcer in the right eye.It occurs constantly.The onset was progressive.Patient states that last monday she was started on a steroid drops for a viral infection.Patient was then seen by ecp on (b)(6) 2020 and was diagnosed with a corneal ulcer and was started on anticholinergics and antibiotic eye drop.Patient states hat her eye feels very irritated and painful, patient describes the pain as "achy".Patient states that her eye is light sensitive as well and she sometimes has a mucus like discharge.Patient states her vision has also became blurred.Upon external examination revealed photophobia, pharm dilated pupil in od.Slit lamp examination revealed white and quiet conjunctiva in ou; cornea: 4mm x 5mm infiltrate (4.7mm x 4.6mm after scraping) in od; anterior chamber: 1.7mm hypopyon in od.Fundus examination revealed red reflex view in od.On (b)(6) 2020, scrape cornea procedure was performed for diagnostic smear in right eye.On the same day, ulcer of the right cornea and amblyopia of right eye was assessed.Antibiotic eye drop was given every hour and anticholinergics three times a day.On (b)(6) 2020, patient states the pain level is at 7 and condition is constant without any pattern.External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 2+ injection in od; cornea: paracentral suptemp infiltrate 3mm x 4mm; overlying debris, overlying staining 4.25 mm x 4.5mm diffuse edema in od; anterior chamber: 1.7mm layered hypopyon in od.On the same day, slight improvement was noted with appearance of slight improvement of infiltrate size, appearance as well as overlying minimal epithelial growth after corneal culture yesterday.No pmn/organisms noted on gram stain.On (b)(6) 2020, patient still experienced the symptoms and the condition remains constant.External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 5mm x 5mm; overlying staining 5x5 mm, diffuse edema; normal iris in od, anterior chamber: ~2mm layered hypopyon in od.Cornea scrape procedure was performed for diagnosis in the right eye.And no growth culture was noted till date, and natamycin was recommended to be initiated.On (b)(6) 2020, patient still experienced symptoms and associated symptoms included decreased vision.External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 5mm x 5mm; overlying staining 4.5x5 mm possible epi ridge nasal diffuse edema; normal iris in ou, anterior chamber: ~2mm layered hypopyon in od.Patient was diagnosed with ulcer of right cornea, hypopyon, amblyopia of right eye.On (b)(6) 2020, patient complained of constant, progressive condition, noted some pain when using the anti-fungal medication.Patient states that the medication causes her eye to throb and burn along with leaving a lot of residue and stopped using the natamycin due to side effects.Patient denies change in vision.External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 5mm x 5mm; overlying staining 3.7x 3.7 mm possible epi ridge nasal diffuse edema, anterior chamber: 1.2mm layered hypopyon (improved slightly) in od.Patient was diagnosed with slight improvement in ulcer of right cornea, hypopyon of right eye.Contact lens and case were brought in for cultures.On (b)(6) 2020, patient's condition was moderate and onset was progressive.Patient was tolerating natacyn only bid.External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 4mm x 4mm; overlying staining 3.7x 3.4 mm with 360 epi ridge diffuse edema has improved, anterior chamber: 0.5mm layered hypopyon (improved slightly), fibrin in ac in od.Patient's vision and exam improved and medication was continued in reduced dosage.On (b)(6) 2020, patient states that her vision and the pain and light sensitivity have improved.The patient continues to apply vancomycin every 2 hours, natamycin was stopped because her eye was throbbing and she" couldn't handle it any longer".External examination revealed dilated pupil in od.Slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 4mm x 3.2mm; overlying staining 3.7x 3.4 mm with 360 epi ridge diffuse edema has improved,anterior chamber: 0.5mm layered hypopyon (improved slightly), fibrin in ac in od, deep and quiet anterior chamber in os.Patient's condition is stable, culture showed filamentous fungus and aggressive treatment plan was followed.On (b)(6) 2020, patient's condition was little better and external examination revealed dilated pupil in od, round and reactive pupil, slit lamp examination revealed conjunctiva: 3+ injection in od; cornea: paracentral suptemp infiltrate ~ 3mm x 3.1mm; overlying staining 3.7x 3.4 mm with 360 epi ridge diffuse edema has improved, anterior chamber: <0.5mm layered hypopyon (improved slightly), fibrin in ac in od.Patient's condition was improving, hypopyon of right eye was resolving.On (b)(6) 2020, patient notes pain and tearing has returned.Patient denies discharge or burning.Patient notes light sensitivity.Patient notes her vision has been stable since her last visit.External examination was unable to assess due to ulcer in od, difficult to assess due to photophobia; confrontational visual fields revealed unable to see fingers in od, slit lamp examination revealed conjunctiva: 3+ injection in od, cornea: paracentral suptemp infiltrate ~ 2.4mm x 3mm; overlying staining 3.7x 3.4 mm with 360 epi ridge diffuse edema has improved anterior chamber: 1.4x3mm layered hypopyon consolidated (improved slightly), fibrin in ac in od, patient was prescribed voriconazole due to fungal corneal ulcer, hypopyon was resolving.On (b)(6) 2020, patient states she has improved starting the new drop and is not light sensitive.External examination was difficult to observe in od,; confrontational visual fields revealed abnormal field temporarily in od, slit lamp examination revealed conjunctiva: 3+ injection in od; cornea: paracentral suptemp infiltrate ~ 2mm x 2.9mm; overlying staining 2x 2.9mm with 360 epi ridge diffuse edema has improved, anterior chamber: scant hypopyon, fibrin resolved in od.On (b)(6) 2020, patient denies pain or irritation, however notes tearing, occasional light sensitivity.Patient notes vision has improved.External examination was difficult to observe in od due to ulcer, confrontational visual fields revealed full to finger counting in ou.Slit lamp examination revealed conjunctiva: 3+ injection in od; cornea: paracentral suptemp infiltrate ~ 3.5mm x 3.5mm; epi defect 2mmx 2mm with 360 epi ridge diffuse edema has improved, anterior chamber: micro hypopyon in od.On (b)(6) 2020, patient's condition was improving, has some tearing.Patient denies any decreased vision, pain or irritation.External examination was hazy view, appears round and reactive in od (bright: 2.5mm), slit lamp examination revealed conjunctiva: 3+ injection in od; cornea: paracentral suptemp infiltrate ~ 3.5mm x 3.5mm; epi defect resolved with 360 epi ridge diffuse edema has improved, anterior chamber: hypopyon has resolved.On (b)(6) 2020, patient still complaints of tearing and notes vision improvement.Denies pain, irritation, burning, discharge or light sensitivity.External examination reveals pupils appear equal, round, reactive, no apd (bright: 1.5mm, dim: 2mm) in od; confrontational visual fields revealed full to finger counting in od; slit lamp examination revealed conjunctiva: 3+ injection in od; cornea: paracentral suptemp infiltrate ~ 3.8mm x 4.5mm at pupillary edge, most dense area 1.5mm, sup knv; diffuse edema has improved, anterior chamber: hypopyon has resolved.Treatment plan included discontinuation of tobramycin and continued other drop regimen.On (b)(6) 2020, patient complaints of fatigued eye and tearing.External examination reveals pupils appear equal, round, reactive.Slit lamp examination revealed conjunctiva: 1+ injection in od; cornea: paracentral suptemp infiltrate ~ 3.8mm x 4.5mm at pupillary edge, most dense area 1.5mm, sup knv; diffuse edema has improved, anterior chamber: hypopyon has resolved.Treatment plan continues.On (b)(6) 2020, patient states eye was recovering and denies new problems.External examination reveals pupils appear equal, round, reactive.Slit lamp examination revealed conjunctiva: 1+ injection in od; cornea: paracentral suptemp infiltrate ~ 3.8mm x 4.5mm at pupillary edge, most dense area 1.5mm, sup knv, 50% improved from previous; epi ridge resolved, anterior chamber: hypopyon has resolved.Treatment plan continues.On (b)(6) 2020, patient denies any problem and confirmed vision remains stable at the time.External examination reveals pupils appear equal, round, reactive, slit lamp examination revealed conjunctiva: 1+ injection in od, white and quiet os; cornea: paracentral suptemp infiltrate ~ haze is 3.8mm x 4.5mm at pupillary edge, most dense area 1.5mm, sup knv, 50% improved from previous; epi ridge resolved, anterior chamber: hypopyon has resolved in od,.Treatment plan continues.On (b)(6) 2020, patient states condition has improved greatly and deny any change or decrease since last visit.External examination reveals pupils appear equal, round, reactive.Slit lamp examination revealed conjunctiva: tr injection in od, cornea: superotemporal knv and fibrosis in od, anterior chamber: deep and quiet in od.Voriconazole and moxifloxacin was discontinued and tears were given 4 times daily.On (b)(6) 2020, patient denies any problem and discontinued usage of all drops.External examination reveals pupils appear equal, round, reactive.Slit lamp examination revealed conjunctiva: tr injection in od,cornea: superotemporal knv 2mm away from pupillary margin and fibrosis not in va in od, anterior chamber: deep and quiet in ou.Voriconazole and moxifloxacin was discontinued and tears were given 4 times daily.On (b)(6) 2020, patient denies any ocular pain or change in vision.External examination reveals pupils appear equal, round, reactive.Slit lamp examination revealed conjunctiva: tr injection in od, cornea: superotemporal knv 2mm away from pupillary margin and fibrosis not in va, few kp in od, normal endothelium, anterior chamber: deep and quiet in ou.Treatment with tears 4 times daily was recommended.On (b)(6) 2020, patient was resolved from all symptoms.Additional information has been requested.

• Brand Name: AOSEPT PLUS/CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 10116471
• MDR Text Key: 195386706
• Report Number: 1610287-2020-00017
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 0065035820
• Device Lot Number: 311710F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 81