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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOFINITY TORIC (COMFILCON A)
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COOPERVISION MANUFACTURING PUERTO RICO, LLC BIOFINITY TORIC (COMFILCON A) Back to Search Results
Lot Number 12234550101014
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Red Eye(s) (2038); Visual Impairment (2138); Excessive Tear Production (2235); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
No device sample returned for manufacturer analysis.A lot number was provided; 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.As two different devices are indicated in the event, initial incident of the right (od) eye, and secondary incident of the left (os) eye, two event reports are being submitted by the manufacturer for this event.Manufacturer reference number (b)(4), manufacturer report number 2640128-2021-00006.Manufacturer reference number (b)(4), manufacturer report number 9614392-2021-00024.
 
Event Description
The patient reports that they sought medical treatment after feeling discomfort in the eyes with poor vision, inflammation and tearing as well as an abscess on the lid of the right (od) eye.The patient the returned for further care and states they were diagnosed with periorbital cellulitis in the right (od) and prescribed three antibiotics and was told to cease lens wear.After approximately 10 days (1.5 week), the patient states the infection resolved and returned to lens use.The patient states that within hours of instilling new contact lenses she began to experience redness and swelling of the left (os) eyelid and developed an abscess on the left eyelid and sought medical treatment.They state they were then diagnosed with periorbital cellulitis of the left eye and prescribed erythromycin, clindamycin, and bactrim.The patient was able to provide contact information for both their location of purchase as well as all the two treatment facilities; the patients primary care physician and the hospital.Each location was contacted multiple times to obtain further information on the event.Information was returned only by the patients primary care physician; the patient had scheduled a telehealth care appointment as a new patient.The patient reported eye irritation and a small abscess with discharge of the left eye with symptoms persisting for five days.The patient reported the history of periorbital cellulitis of the right eye two weeks prior.At the time of telehealth visit the patient reported no changes in visual acuity.Based on telehealth visit, the patient was diagnosed with periorbital cellulitis of the left eye, they were prescribed bactrim ds for 7 days treatment.The patient was instructed to follow-up with an ophthalmologist or o the er if symptoms did not resolve or new symptoms developed and advised to discontinue lens use until seen by an ophthalmologist or optometrist for follow-up care.Good faith efforts were made to obtain additional information from the patient on the incident and medical treatment received without success, further information is unknown.This event is being reported in an abundance of caution due lack of medical documentation and the potential severity of periorbital cellulitis.While it is unlikely the device was a cause or contributing factor, the relationship between the device and the event is unknown.As two different devices are indicated in the event, initial incident of the right (od) eye, and secondary incident of the left (os) eye, two event reports are being submitted by the manufacturer for this event.Manufacturer reference number (b)(4), manufacturer report number 2640128-2021-00006.Manufacturer reference number (b)(4), manufacturer report number 9614392-2021-00024.
 
Manufacturer Narrative
Correction: report 2640128-2021-00006 initially submitted with details pertaining to *9614392-2021-00024*.This report is being subbmitted with corrected data (lot number, expiry date, and manufacturing date).(h3): no device sample returned for manufacturer analysis.A lot number was provided; 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.As two different devices are indicated in the event, initial incident of the right (od) eye, and secondary incident of the left (os) eye, two event reports are being submitted by the manufacturer for this event.Manufacturer reference number (b)(4), manufacturer report number 2640128-2021-00006 , manufacturer reference number (b)(4), manufacturer report number 9614392-2021-00024.
 
Event Description
The patient reports that they sought medical treatment after feeling discomfort in the eyes with poor vision, inflammation and tearing as well as an abscess on the lid of the right (od) eye.The patient the returned for further care and states they were diagnosed with periorbital cellulitis in the right (od) and prescribed three antibiotics and was told to cease lens wear.After approximately 10 days (1.5 week), the patient states the infection resolved and returned to lens use.The patient states that within hours of instilling new contact lenses she began to experience redness and swelling of the left (os) eyelid and developed an abscess on the left eyelid and sought medical treatment.They state they were then diagnosed with periorbital cellulitis of the left eye and prescribed erythromycin, clindamycin, and bactrim.The patient was able to provide contact information for both their location of purchase as well as all the two treatment facilities; the patients primary care physician and the hospital.Each location was contacted multiple times to obtain further information on the event.Information was returned only by the patients primary care physician; the patient had scheduled a telehealth care appointment as a new patient.The patient reported eye irritation and a small abscess with discharge of the left eye with symptoms persisting for five days.The patient reported the history of periorbital cellulitis of the right eye two weeks prior.At the time of telehealth visit the patient reported no changes in visual acuity.Based on telehealth visit, the patient was diagnosed with periorbital cellulitis of the left eye, they were prescribed bactrim ds for 7 days treatment.The patient was instructed to follow-up with an ophthalmologist or o the er if symptoms did not resolve or new symptoms developed and advised to discontinue lens use until seen by an ophthalmologist or optometrist for follow-up care.Good faith efforts were made to obtain additional information from the patient on the incident and medical treatment received without success, further information is unknown.This event is being reported in an abundance of caution due lack of medical documentation and the potential severity of periorbital cellulitis.While it is unlikely the device was a cause or contributing factor, the relationship between the device and the event is unknown.As two different devices are indicated in the event, initial incident of the right (od) eye, and secondary incident of the left (os) eye, two event reports are being submitted by the manufacturer for this event.Manufacturer reference number (b)(4), manufacturer report number 2640128-2021-00006.Manufacturer reference number (b)(4), manufacturer report number 9614392-2021-00024.
 
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Brand Name
BIOFINITY TORIC (COMFILCON A)
Type of Device
BIOFINITY TORIC (COMFILCON A)
Manufacturer (Section D)
COOPERVISION MANUFACTURING PUERTO RICO, LLC
500 road 584
lot 7
amuelas industrial park, juana diaz 00795
*  00795
MDR Report Key12537296
MDR Text Key273985504
Report Number2640128-2021-00006
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
PMA/PMN Number
P080011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/27/2021
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 Expiration Date02/29/2024
Device Lot Number12234550101014
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/26/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received08/26/2021
Supplement Dates FDA Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age31 YR
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