MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. PROCLEAR MULTIFOCAL (OMAFILCON B); PROCLAER MULTIFOCAL (OMAFILCON B)

Lot Number 16734050013014

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

Patient Problems Corneal Edema (1791); Keratitis (1944); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 04/20/2020

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

It is reported that the patient experienced symptoms of a burning sensation, irritation and periorbital pain of the right (od) eye on (b)(6) 2020 and sought medical treatment.The patient presented with severe epithelial staining, moderate epithelial edema, limbal and bulbar injection, and trace stromal edema.Fluorescein staining identified central spk and a central epithelial defect.The patient was prescribed polytrim, prednisolone 1%, and motrin initially.The following day an amniotic membrane was placed on the right eye.Over the course of treatment and doxycycline and muro 128 were also prescribed.As of (b)(6), all medications and treatments were concluded and the incident fully resolved, however, the treating physician indicates that medical intervention and/or medications were required to prevent or preclude permanent impairment of eye function or structure from the condition of a persistent epithelial defect.

Manufacturer Narrative

Based on investigation, 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: PROCLEAR MULTIFOCAL (OMAFILCON B)
• Type of Device: PROCLAER MULTIFOCAL (OMAFILCON B)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• MDR Report Key: 10277850
• MDR Text Key: 199884970
• Report Number: 9614392-2020-00012
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K123202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Lot Number: 16734050013014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 68