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

Lot Number 11319570255026

Device Problem Nonstandard Device (1420)

Patient Problems Keratitis (1944); Discomfort (2330)

Event Type  Injury  

Event Description

This incident was reported by the customer to the local sales office who reported to the manufacturer.It was reported that the patient experienced discomfort after wearing the lens and sought medical treatment.It is reported that the patient was diagnosed with unspecified keratitis.It is also reported that the patient tried to wear the contact lens after the treatment, but experienced the same symptoms and removed the lens.On november 24, 2023, the ophthalmologist confirmed that the issue was resolved, and the patient was in good ocular health.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 unknown type or severity of the reported keratitis and lack of supporting medical information.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

Device sample received and one lens found to be outside of manufacturers specification for vision corrective prescription.Additional lenses evaluated were within manufacturer specification.While an off power lens may cause or contribute to poor vision correction or poor visual acuity, it is unlikely to have caused or contributed to the patients reported condition of keratitis.Manufacturing records reviewed and no issues or nonconformance's were found and no trends could be identified.The relationship between the cooper vision device and the event could not be confirmed.As patient was using a different device in each eye and it is unknown which or both eyes were involved, both devices are being reported.Please refer to manufacturer report (b)(6), 2640128-2023-00014.

• 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: 18334796
• MDR Text Key: 330598878
• Report Number: 2640128-2023-00013
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11319570255026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female