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

Catalog Number 0065135602

Device Problem Product Quality Problem (1506)

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Burning Sensation (2146)

Event Date 08/22/2022

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 reported by consumer on behalf of her brother-in-law who is a long-time user of the product, experienced stinging sensation of eye, sought medical attention and was diagnosed with right eye cornea and conjunctival sac erosion.Two bottles of solution were mentioned, upon opening both the bottles, one had transparent solution whereas another bottle that was drop in eye had blue colored solution.The current status of consumer¿s eye is resolved at the time of this report.Additional information regarding the event has been requested but not yet received.

Event Description

Additional information received stated that the suspect product was tested independently, showing an acidic ph value.Multiple attempts to have the complaint sample returned have been made, however it has not been received for evaluation to date.

Event Description

An additional information was received.Which showed the attorney indicated, that the consumer brought the solution online.And seems like doubting, if it is a counterfeit.

Event Description

An additional translated medical document was received which showed the consumer was diagnosed with right corneal and conjunctival sac erosion and was hospitalized for three hours to receive treatment.It was also reported that patient used lens care solution (putting it directly into the eye) for a long time, and experienced stinging only at this time.Later, it was confirmed by a consumer relative that the patient used lens care properly (not directly putting it into the eye).New event h-conjunctivitis was added as a correction.

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

• 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
• 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: 15355520
• MDR Text Key: 299279111
• Report Number: 1610287-2022-00065
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K050729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 0065135602
• Device Lot Number: 10435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male