MAUDE Adverse Event Report: COOPERVISION LENS CARE LTD. ALL IN ONE LIGHT (MULTI-PURPOSE SOFT/RIGID CONTACT LENS SOLUTION)

Lot Number 168321

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Eye Infections (4466); Eye Pain (4467)

Event Type  Injury  

Event Description

This incident was reported by the patient, to their location of purchase, who provided the information to the manufacturer.Limited information has been made available.It was alleged that the patient experienced irritation when using multipurpose solution on her contact lens which developed into an eye infection and unspecified antibiotic/steroid medications were prescribed.The issue was resolved with switching to a different lens care solution product.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the lack of medical information and unconfirmed diagnosis.

Manufacturer Narrative

Device sample received and evaluation underway but not yet complete.Refer to relevant tests/laboratory data for additional details.A follow-up report will be submitted upon completion of device evaluation.

Manufacturer Narrative

Corrected data: this incident was initially reported 11 april 2023.At the time of report, sample had been received and analysis pending completion.Analysis completed; this report has been updated to reflect the final inspection results.Manufacturer narrative: no issues or non-conformances were found in manufacturing records and no trends identified.The product was manufactured and released within all specification.Returned same had no defects or failures identified and was withing manufacturing specification.It is unknown if the device caused or contributed to the patient's condition.Based on manufacturing investigation, a root cause could not be established.

• Brand Name: ALL IN ONE LIGHT (MULTI-PURPOSE SOFT/RIGID CONTACT LENS SOLUTION)
• Type of Device: ALL IN ONE LIGHT (MULTI-PURPOSE SOFT/RIGID CONTACT LENS SOLUTION)
• Manufacturer (Section D): COOPERVISION LENS CARE LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): COOPERVISION LENS CARE LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: melissa torpey ; 209 high point drive; suite 100; victor, NY 14564 ; 5857569874
• MDR Report Key: 16712391
• MDR Text Key: 313012166
• Report Number: 9615939-2023-00002
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2023
• Device Lot Number: 168321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female