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

Lot Number 11317050055508

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

Patient Problems Abscess (1690); Cataract (1766); Corneal Edema (1791); Corneal Ulcer (1796); Eye Injury (1845); Hypopyon (1913); Intraocular Infection (1933); Keratitis (1944); Neovascularization (1978); Pain (1994); Blurred Vision (2137); Burning Sensation (2146); Corneal Infiltrates (2231); Discomfort (2330); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

No product was returned to the manufacturer for device evaluation and no lot number provided.The manufacturer is unable to investigate further at this time.Should further information become available, coopervision will submit a follow-up report.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

Information received from the distributor.The patient alleges that they experienced an infection of the eye that led to a corneal transplant.Good faith efforts have been made to obtain additional info without success, additional info is unknown.This event is being reported in an abundance of caution due to lack of medical info, incomplete diagnosis, and unknown resolution.

Manufacturer Narrative

(h3): no product was returned to the manufacturer for device evaluation and no lot number provided.The manufacturer is unable to investigate further at this time.Should further information become available, coopervision will submit a follow-up report.The relationship between the coopervision device and the incident is unconfirmed.For new/updated information see: (b5-6), (d1-2), (d4), (g3-g5), (g7), (h2), (h4), (h6), (h10) - attachment: [attachment 1 - treatment history.Pdf].

Event Description

New medical information received the patient began using the device in may and on the fourth day of use experienced discomfort in the right (od) eye.The patient notes that the lens was damaged and removed from the eye.The following day, 11 may 2018, the patient was experiencing eye irritation and soreness and sought medical treatment at ophthalmological institute of dr.(b)(6) in (b)(6) city.The patient was diagnosed with a 1mm central corneal ulcer with no signs of infection and prescribed erythromycin.The patient was seen for several follow-up visits through july and was prescribed several medications.On (b)(6)the patient was referred from dr.Brunzini to dr.Charles opthalmology center with a diagnosis of a right eye corneal infection with anterior chamber inflammation and a post infection cataract.The patient was told they may require cataract surgery or corneal transplant surgery.The patient was seen for several follow-up visits at dr.Charles ophthalmology center awaiting the corneal transplant and cataract surgery from august through november 2018.On 25 april 2019 the patient underwent a successful corneal transplant that then required ten months of periodic follow-up care.As of the date of medical records provided (18 february 2020) follow-up care for the transplant is ongoing.Based on medical records or medical documentation provided, a full history of the patient's treatment, as provided, is attached to this report, see attachment 1 - treatment history.

Manufacturer Narrative

Additional medical information received regarding patients continued care and medical treatment.As of date of last med records received some alleged treatments are unconfirmed.This incident remains unresolved based on medical records received.The relationship between the coopervision device and adverse event is unconfirmed.

Event Description

Additional medical information received regarding patients continued care and medical treatment regarding dalk, faco, and iol.As of date of last med record ((b)(6) 2021) iol placement is unconfirmed, based on records received.Patient states that iol was placed (b)(6) 2020 and after post-operative care completion, blepharoplasty will be required to resolve a drooping / disfigured eye lid, this information is not confirmed by medical records provided.This incident remains unresolved based on medical records received.Based on medical records or medical documentation received, a history of the patient's treatments and status, as provided, is attached to this report, see attachment 1 - treatment history.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 9604891
• MDR Text Key: 176029824
• Report Number: 9614392-2020-00002
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 11317050055508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2017
• 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 Sex: Female