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

Lot Number 11416570067012

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

Patient Problems Corneal Edema (1791); Acanthameba Keratitis (1945); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Corneal Infiltrates (2231); Eye Infections (4466)

Event Date 11/26/2023

Event Type  Injury  

Manufacturer Narrative

(h3): no device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

This incident was reported by the contact lens distributor with additional information supplied by the treating physician.It is reported that the patient experienced redness, photophobia, blurry vision, burning sensation in the right eye (od) on november 26, 2023, and sought medical treatment the following day.Examination identified a paracentral infiltrate and inferior hypopyon with associated epithelial staining, epithelial and stromal edema and bulbar injection.The patient was diagnosed with infectious keratitis, corneal cultures identified pseudomonas aeruginosa and staphylococcus epidermidis, and was treated with floxal cefazolin, doxycycline, scopolamine and vitamin a cream.Information on follow-up visit(s) has not been made available to date.Good faith efforts have been made to obtain additional 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 diagnosis of infectious keratitis and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Manufacturers investigation of the returned device and manufacturing records found no failures or nonconformances and no trends were identified.No root cause could be established, the relationship between the coopervision device and the incident is unconfirmed.Device sample returned for analysis, received on 02 january 2024 and investigation completed on 02 january 2024.For updated data refer to the following sections: (b4), (b6), (d9), (g2), (g3), (g6), (h2), (h3), (h4), (h6), (h10).

• 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
• 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: 18403336
• MDR Text Key: 331477069
• Report Number: 2640128-2023-00018
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11416570067012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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