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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 11317170111517
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Visual Impairment (2138); Eye Pain (4467)
Event Date 12/17/2022
Event Type  Injury  
Event Description
This incident was reported by patient and limited information is known.The patient states after uses of the contacts, she experienced pain in the right (od) eye and sought medical treatment at memorial hospital on (b)(6) 2022.The patient was prescribed eye drops (unspecified) but continued to experience discomfort and discovered a contact lens still in her eye.Upon removal, the patient indicates she lost vision in the affected eye.The patient was seen by her ecp on (b)(6) 2022 who diagnosed a central corneal ulcer and referred the patient to bascom palmer hospital for treatment.The patient states the ulcer was measured as 5mm, located centrally in her eye.Per the patient, treatment has included cyclopentolate, erythromycin, vancomycin, tobramycin, prednisolone, moxifloxacin, and tobramycin, plus frequent use of systane rewetting drops.As of (b)(6) 2023 the patient reports continued decreased vision in the right eye and ongoing treatment.Good faith efforts have been made to obtain additional information without success; as of the date of this report additional information is unknown.This event is being reported with an abundance of caution due to the indicated central location of the corneal ulcer with a lack of medical information, and ongoing unresolved status.Should further information become available, a follow-up report will be submitted as appropriate.
 
Manufacturer Narrative
(see h3) no product has been made available for manufacturer analysis.Lot number was provided for the device alleged to be involved in the incident.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.
 
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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
jose rodriguez
209 high point dr
victor, NY 14564
5857569847
MDR Report Key16939772
MDR Text Key315312694
Report Number9614392-2023-00015
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/16/2023
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 Number11317170111517
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/18/2023
Initial Date FDA Received05/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
Patient SexFemale
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