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U.S. Department of Health and Human Services

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

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COOPERVISION MANUFACTURING, LTD BIOFINITY SPHERE (COMFILCON A) Back to Search Results
Lot Number 11317050109518
Device Problem Break (1069)
Patient Problem Eye Infections (4466)
Event Type  Injury  
Manufacturer Narrative
Sealed device(s) returned in unused condition were within manufacturing specification, free from any faults or failures.The open device returned in used condition was damaged and could not be evaluated, no root cause for the damage could be identified.Record review found no issues, nonconformances, or trends.The relationship between the coopervision device and the incident is unconfirmed.As patient was using a different device in each eye and it is unknown which or both eyes were involved, both devices are being reported.Please refer to manufacturer report (b)(4) 9614392-2023-00011.
 
Event Description
This incident was reported by the optician to the manufacturer.It was reported that the patient experienced torn lens in the eyes and sought medical treatment.Alleged that the patient was diagnosed with eye infection and was treated with unspecified antibiotics and lubricant.The issue was resolved in seven (7) days.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 the unknown type or severity of the alleged infection and lack of supporting medical information.Should further information become available, a follow-up report will be submitted as appropriate.
 
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Brand Name
BIOFINITY SPHERE (COMFILCON A)
Type of Device
BIOFINITY SPHERE (COMFILCON A)
Manufacturer (Section D)
COOPERVISION MANUFACTURING, LTD
south point , hamble unit 2
southampton, hampshire SO31 4RF
UK  SO31 4RF
Manufacturer (Section G)
COOPERVISION MANUFACTURING, LTD
south point , hamble unit 2
southampton, hampshire SO31 4RF
UK   SO31 4RF
Manufacturer Contact
spandana mannepalli
209 highpoint drive
suite 100
victor, NY 14564
5857569688
MDR Report Key16776124
MDR Text Key313647440
Report Number9614392-2023-00012
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P080011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number11317050109518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2023
Initial Date FDA Received04/20/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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