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

Lot Number ASKU

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

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Corneal Infiltrates (2231)

Event Type  Injury  

Event Description

As reported the retrospective study of contact lens daily wearer and extended wearer was performed, in which out of 88 patients 55 patients have experienced corneal inflammatory events (cie) which includes contact lens peripheral ulcer (clpu), infiltrative keratitis (contact lens acute red eye, contact lens associated infiltrative keratitis, asymptomatic infiltrates, asymptomatic infiltrative keratitis, or scattered infiltrates) and phlyctenular-like condition defined as limbal edema with adjacent, but localized, corneal edema and infiltrates.Mixed, conditions where two of the three listed above were present simultaneously.The treatment medication included steroid and antibiotic combination, followed by antibiotic only or steroid only.The outcome of the events were not reported.No further information is available.As initially reported by the health professional via literature on (b)(6) 2020, it was reported that out of 76 patients 55 patients have experienced corneal inflammatory events (cie) which includes contact lens peripheral ulcer (clpu) and infiltrative keratitis (contact lens acute red eye, contact lens associated infiltrative keratitis, asymptomatic infiltrates, asymptomatic infiltrative keratitis, or scattered infiltrates).Mixed, conditions where two of the three listed above were present simultaneously.The outcome of the events were not reported.

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.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).

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.Prior to product release, all chemistry and microbial finished product results, environmental, utility records and sanitization records were reviewed.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13505739
• MDR Text Key: 285397293
• Report Number: 1610287-2022-00007
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other