MAUDE Adverse Event Report: COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOFINITY SPHERE (COMFILCON A)

Lot Number 11320550147014

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

No device sample returned for manufacturer analysis.A lot number was reported to the manufacturer and investigation is ongoing.A follow-up report will be submitted.

Event Description

It is reported that after a patient was diagnosed with bacterial keratitis (see manufacturer reference 9614392-2021-00002 / (b)(4)), sealed lenses from in store inventory (diagnostic device) were sent to a third party facility for testing.These lenses were the same prescriptions in that of those used by the patient but the lot numbers were unrelated to the patient incident.The lenses were opened by the testing facility and labeled as "lens 1" and "lens 2".No lot or prescription information was recorded by the testing facility.One of the samples tested positive for the presence of the pseudomonas aeruginosa bacterium.The two lot numbers of the tested product were provided to the manufacturer, due to lack of data recording at the testing facility, the manufacturer is unable to confirm which lot was identified as affected.No lenses have been returned to the manufacturer for device analysis.Investigation of the alleged involved lots is ongoing, a follow-up report to be submitted.Good faith efforts have been made to obtain further information without success, additional information is unknown.This event is being reported in an abundance of caution due the allegation of contaminated product without supporting details or the manufacturers ability to confirm results.See manufacturer reference number 9614392-2021-00004 for secondary lot number being investigated.

Event Description

It is reported that after a patient was diagnosed with bacterial keratitis (see manufacturer reference 9614392-2021-00002 / cc457801), sealed lenses from in store inventory (diagnostic device) were sent to a third party facility for testing.These lenses were the same prescriptions in that of those used by the patient but the lot numbers were unrelated to the patient incident.The lenses were opened by the testing facility and labeled as "lens 1" and "lens 2".No lot or prescription information was recorded by the testing facility.One of the samples tested positive for the presence of the pseudomonas aeruginosa bacterium.The two lot numbers of the tested product were provided to the manufacturer, due to lack of data recording at the testing facility, the manufacturer is unable to confirm which lot was identified as affected.No lenses have been returned to the manufacturer for device analysis.Investigation of the alleged involved lots is ongoing, a follow-up report to be submitted.Good faith efforts have been made to obtain further information without success, additional information is unknown.This event is being reported in an abundance of caution due the allegation of contaminated product without supporting details or the manufacturers ability to confirm results.See manufacturer reference number 9614392-2021-00004 for secondary lot number being investigated.Manufacturers investigation is ongoing as of 11 february 2021.Follow-up report(s) to be submitted as scheduled and/or at the completions of the investigation.

Manufacturer Narrative

(h3): no device sample returned for manufacturer analysis.A lot number was reported to the manufacturer and investigation is ongoing.A follow-up report will be submitted.

Event Description

It is reported that after a patient was diagnosed with bacterial keratitis (see manufacturer reference (b)(4)), sealed lenses from in store inventory (diagnostic device) were sent to a third party facility for testing.These lenses were the same prescriptions in that of those used by the patient but the lot numbers were unrelated to the patient incident.The lenses were opened by the testing facility and labeled as "lens 1" and "lens 2".No lot or prescription information was recorded by the testing facility.It is reported that one of the samples tested positive for the presence of the pseudomonas aeruginosa bacterium.The two lot numbers of the tested product were provided to the manufacturer, due to lack of data recording at the testing facility, the manufacturer is unable to confirm which lot was identified as affected.Good faith efforts have been made to obtain further information without success, additional information is unknown.This event is being reported in an abundance of caution due the allegation of contaminated product without supporting details or the manufacturers ability to confirm results.See manufacturer reference number (b)(4) for secondary lot number being investigated.

Manufacturer Narrative

(h3): no device sample returned for manufacturer analysis.A lot number was reported to the manufacturer and investigated.No root cause could be identified, no relationship between be coopervision device and the incident could be confirmed.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING PUERTO RICO, LLC; 500 road 584; lot 7; amuelas industrial park, juana diaz 00795
• MDR Report Key: 11157997
• MDR Text Key: 232578385
• Report Number: 2640128-2021-00001
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 11320550147014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other