MAUDE Adverse Event Report: COOPERVISION, INC. BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)

Lot Number 12643900780015

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Eye Infections (4466); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  Injury  

Event Description

The incident was reported by the end user and limited information has been made available.It is reported that on (b)(6) the patient sought medical treatment and was diagnosed with a corneal ulcer of unspecified severity and location.On (b)(6), after treatment, the patient resumed lens used and reportedly experienced an infection of the eye on (b)(6).Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to unknown nature and severity of the incident, the lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.It is unknown if the incident affected the right (od), left (os), or both (ou) eyes.As the patient was using a different device in each eye, please refer to associated manufacturer report cc534897 1314956-2023-00006.

Manufacturer Narrative

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

This incident was originally reported on 22 august 2023 in an abundance of caution an alleged corneal ulcer with lack of supporting medical information and unknown or unconfirmed device involvement.Medical information from the treating physician received on 30 august 2023 confirmed that the incident did not involve this device; there was no injury or illness associated with the use of this device.As such, the manufacturer finds that this no longer meets the criteria for a reportable adverse event.For a reportable event, please refer to manufacture report cc534897/ 1314956-2023-00006.

Manufacturer Narrative

Manufacturers investigation of the returned device and manufacturing records found no failures or nonconformances and notrends were identified.No root cause could be established, the relationship between the coopervision device and the incident is unconfirmed.Device sample returned for analysis, received 29 august 2023 and investigation completed on 29 aug 2023.Additional relevant medical information was received on 31 aug 2023.For updated data refer to the following sections: (a2),(a3), (b3), (b4), (b5) (b6), (d9), (g2) (g3) (g6), (h2), (h3), (h4), (h6), (h10).

• Brand Name: BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)
• Type of Device: BIOMEDICS 55 UV ASPHERIC (OCUFILCON D)
• Manufacturer (Section D): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer (Section G): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer Contact: spandana mannepalli ; 209 highpoint drive; suite 100; victor, NY 14564 ; 5857569688
• MDR Report Key: 17599496
• MDR Text Key: 321694231
• Report Number: 1314956-2023-00005
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P890023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12643900780015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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 Age: 39 YR
• Patient Sex: Female