MAUDE Adverse Event Report: COOPERVISION, INC PROCLEAR TORIC (OMAFILCON B)

Lot Number 10431500070024

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

Patient Problems Dry Eye(s) (1814); Red Eye(s) (2038); Uveitis (2122); Excessive Tear Production (2235)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

No lenses returned for analysis.No root cause could be established from investigation, the relationship between the coopervision device and the incident is unconfirmed.

Event Description

The incident was initially reported by the patient/user as uveitis with no further details.Additional information received from the patients treating eye care provider.The patient sought medical treatment for symptoms of irritation, redness, photophobia, and watering/discharge of the right (od) eye.The treating eye care provider notes clinical findings of epithelial mild to moderate staining, mild bulbar injection, trace papillae, and trace (5-6) cells.The patient was diagnosed with mild uveitis secondary to contact lens associated red eye and/or dry eye with a history of idiopathic uveitis.The patient was treated with polytrim, prednisolone acetate, and xiidra (lifitegrast) for one week.Patient was seen for follow up at three days with minimal improvement.Patient was prescribed moatropine, maxitrol, and pred forte in addition to previously prescribed medications for one week.Patient was seen for two week follow-up after being seen by uveitis specialist, patient indicates was prescribed durezol and cyclopentalate but no medical records provided for this visit, with improved symptoms.Durezol and cyclopentalate have been discontinued at the advice of the uveitis specialist and all previously prescribed medications from the primary treating eye care provider previously discontinued.Eye care provider notes trace inferior superficial punctate keratitis and no cells, dryness is improving and uveitis has resolved.While patient has a history of idiopathic uveitis, it is the opinion of the treating eye care provider that this incident was associated with the use of contact lenses and medical treatment and/or medication was required to prevent or preclude permanent impairment of the eye function or structure.

Manufacturer Narrative

No issues or non-conformances were found, no root cause could be established.The relationship between the coopervision device and the event is unconfirmed.

• Brand Name: PROCLEAR TORIC (OMAFILCON B)
• Type of Device: PROCLEAR TORIC (OMAFILCON B)
• Manufacturer (Section D): COOPERVISION, INC; 711 north road; scottsville NY 14546
• MDR Report Key: 10864034
• MDR Text Key: 217077399
• Report Number: 1314956-2020-00002
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 10431500070024
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR