MAUDE Adverse Event Report: COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)

Lot Number 12290520160019

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

Patient Problems Corneal Scar (1793); Visual Impairment (2138); Eye Pain (4467)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

See (h3) no device sample was returned for manufacturer analysis.Investigation of the provided lot number found no issues or non-conformances and no trends were identified.No root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available, a follow-up report will be submitted as appropriated.

Event Description

This incident was initially reported by the patient with additional information provided by the treating physician.The patient sought treatment on (b)(6) 2023 for persistent pain in her right (od) eye, which had been ongoing since july.Upon examination, the physician observed a corneal scar or opacity, location unspecified though it is noted to be peripheral, and diagnosed the patient with limbal stem cell deficiency, a condition that can pose a threat to vision.The physician also indicates conjunctivalization as a result of the limbal stem cell deficiency, which they believe to be related to overwearing.The physician recommended over the counter artificial tears.The patient was seen for the initial visit and one follow-up but patient did not return for any further follow-up care.The patient states that after one month of discontinuation they have resumed lens use without issue and have not sought further medical attention.This event is being reported due to the diagnosis of limbal stem cell deficiency and the potential for serious or permanent injury.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Device sample returned for analysis, received march 07, 2024, and analysis completed on march 14, 2024.Manufacturers incident report is updated to reflect the results of device analysis and investigations.Based on manufacturer analysis of the returned device(s) and investigation, no root cause could be established.The relationship between the coopervision device and the event is unconfirmed.Should additional information become available additional investigation will be completed and a follow-up submitted as appropriate.

• Brand Name: BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)
• Type of Device: BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)
• Manufacturer (Section D): COOPERVISION MANUFACTURING PUERTO RICO, LLC; 500 road 584 lot 7; amuelas industrial park, juana diaz 00795 ; * 00795
• Manufacturer (Section G): COOPERVISION MANUFACTURING PUERTO RICO, LLC; 500 road 584 lot 7; amuelas industrial park, juana diaz 00795 ; * 00795
• Manufacturer Contact: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 18758292
• MDR Text Key: 336000669
• Report Number: 2640128-2024-00009
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12290520160019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2022
• 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): Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female