MAUDE Adverse Event Report: COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOFINITY SPHERE (COMFILCON A)

Lot Number 11316570048034

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

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Keratitis (1944); Corneal Infiltrates (2231); Eye Pain (4467)

Event Date 11/02/2023

Event Type  Injury  

Event Description

This incident was reported to the manufacturer through the provider's office.It was reported that the patient sought medical attention for eye pain and light sensitivity on november 02, 2023, while using the contact lens, which were approximately 3 weeks old.Medical records received indicate examination showed five subepithelial infiltrates with corneal edema and trace cells in anterior chamber of the right eye (od).The patient was diagnosed with infiltrative keratitis, treated with tobradex eye drops to be instilled every four hours for four days.It is reported that the incident has resolved as of november 17, 2023, without any permanent damage and the patient has resumed lens use.This incident is being reported due to the indication of medical intervention required to prevent permanent impairment of eye function or structure from potentially related to further infiltrative events or vision loss related to scaring.Should additional information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Manufacturers investigation and analysis of reported device lot number and returned samples found no issues, non-conformance's, or trends identified.The relationship between the cooper vision and the event could not be confirmed.Should additional information become available, a follow-up report will be submitted as appropriate.The patient returned samples from two manufacturer lot numbers for devices potentially involved in the event.As is it unknown which, or if both, were involved, please refer to manufactures report cc544523 2640128-2023-00012.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• 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: spandana mannepalli ; 209 highpoint drive; suite 100; victor, NY 14564 ; 5857569688
• MDR Report Key: 18334529
• MDR Text Key: 330596366
• Report Number: 2640128-2023-00011
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080011
• 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: 12/15/2023

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: 11316570048034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 72 KG