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

Lot Number 11317550155006

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

No product was returned to the manufacturer for device evaluation.A lot number was received, 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

The patient alleges that over a two-month time period, she developed two bacterial eye infections while using the device.Good faith efforts have been made to obtain additional information without success, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown resolution.

Event Description

The patient alleges that over a two-month time period, she developed two bacterial eye infections while using the device.Good faith efforts have been made to obtain additional information without success, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown resolution.

Manufacturer Narrative

Corrected information received for location of manufacture, follow-up report to correct suspect medical device manufacturing location and provide updated manufacturer report number.As the manufactuirng site is being corrected, please use new manufacturer report number 2640128-2020-00003.

• 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
• MDR Report Key: 9939183
• MDR Text Key: 194018191
• Report Number: 9614392-2020-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Lot Number: 11317550155006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other