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

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Hypopyon (1913); Keratitis (1944); Corneal Infiltrates (2231)

Event Date 10/26/2019

Event Type  Injury  

Manufacturer Narrative

No device sample returned for manufacturer analysis and no lot number reported, no investigation could be completed, and no root cause established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

It was initially reported by the patient's mother that the patient experienced a corneal ulcer in the left (os) eye on (b)(6) 2019.The patient was seen for several follow-up visits at by multiple eye care providers and was on medication for approximately four months and is anticipated to be left with permanent vision reduction.Additional information obtained from the eye care provider, based on record review, indicates the patient presented with severe epithelial staining, severe corneal infiltrates, central epithelial defect and hypopyon and was diagnosed with a bacterial corneal ulcer, suspected pseudomonas.Cultures were taken but were discarded due to lab error and not retaken.The patient was prescribed tobramycin and vancomycin.Patient was last seen (b)(6) 2020 and the incident remains unresolved.It is stated that the medical intervention was required to treat the conditions of a central corneal injury with scar penetrating bowman's layer and infectious corneal ulcer.The incident resulted in or it is anticipated will result in a corneal opacity within the central area of the corneal and a permanent reduction in visual acuity.

• Brand Name: BIOFINITY TORIC (COMFILCON A)
• Type of Device: BIOFINITY TORIC (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 10789326
• MDR Text Key: 214755171
• Report Number: 9614392-2020-00016
• 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: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 16 YR