MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. BIOFINITY SPHERE (COMFILCON A)

Lot Number 11317170111517

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

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Visual Impairment (2138); Eye Pain (4467)

Event Date 12/17/2022

Event Type  Injury  

Event Description

This incident was reported by patient and limited information is known.The patient states after uses of the contacts, she experienced pain in the right (od) eye and sought medical treatment at memorial hospital on (b)(6) 2022.The patient was prescribed eye drops (unspecified) but continued to experience discomfort and discovered a contact lens still in her eye.Upon removal, the patient indicates she lost vision in the affected eye.The patient was seen by her ecp on (b)(6) 2022 who diagnosed a central corneal ulcer and referred the patient to bascom palmer hospital for treatment.The patient states the ulcer was measured as 5mm, located centrally in her eye.Per the patient, treatment has included cyclopentolate, erythromycin, vancomycin, tobramycin, prednisolone, moxifloxacin, and tobramycin, plus frequent use of systane rewetting drops.As of (b)(6) 2023 the patient reports continued decreased vision in the right eye and ongoing treatment.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 with an abundance of caution due to the indicated central location of the corneal ulcer with a lack of medical information, and ongoing unresolved status.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

(see h3) no product has been made available for manufacturer analysis.Lot number was provided for the device alleged to be involved in the incident.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.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point, hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point, hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 16939772
• MDR Text Key: 315312694
• Report Number: 9614392-2023-00015
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11317170111517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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