MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE PUREMOIST 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 Ulcer (1796); Erythema (1840); Inflammation (1932); Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: 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).

Event Description

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

H.3., h.6.: chemistry and micro data must meet regulatory requirements prior to each batch.A sample or lot code would be required for further investigation.As insufficient information was provided for investigation, a conclusive root cause cannot be determined for the corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint conditions.Consumer mishandling, consumer physiology, and unrelated events could not be eliminated as potential root causes.Potential root causes of corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint condition include: ¿ solution quality issue ¿ unlikely, as chemistry and microbiology results must meet regulatory requirements prior to release of a lot.¿ consumer mishandling - no conclusion can be made regarding the contribution of consumer mishandling as this factor is outside the control of the manufacturing facility.¿ event related to consumer physiology ¿ no conclusion can be made regarding the contribution of unique consumer physiology as this factor is outside the control of the manufacturing facility.¿ event unrelated to product use - no conclusion can be made regarding this root cause based on information available.A sample or lot code would be required for review of the analytical testing results and complaint history associated with the reported lot.Insufficient information provided to determine a conclusive root cause for the corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint conditions.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Correction in d.1, d.3, and corrected information in g.9.The initial mdr and first follow-up report were incorrectly under mfr report# 1610287-2020-00013.This report references the correct mfr report # 1610287-2022-00010.All future reports associated with this product event will be submitted under report # 1610287-2022-00010.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H3, h6: 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 PUREMOIST 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: 9843477
• MDR Text Key: 183920035
• Report Number: 1610287-2020-00013
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2022

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: 02/19/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/21/2020; 01/26/2022; 03/04/2022
• Supplement Dates FDA Received: 04/22/2020; 02/12/2022; 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: CORRECTION
• Patient Sequence Number: 1
• Patient Outcome(s): Other