MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-18 for OPTIONS MULTI SOLUTION manufactured by Coopervision Manufacturing Limited.
[21318329]
On 19nov2013, coopervision was advised by an optician that a patient was diagnosed with acanthamoeba keratitis after using options multi solutions with biofinity contact lenses. Follow-up medical information was received on 22nov2013. The medical report only describes the use of options multi solution. It does not allege any issues or describe any contact lens information other than contact lens use was permanently discontinued. Therefore, this is reported in relation to the contact solution. The report describes onset of a left eye ulcer of (b)(6) 2013, which required hospitalization for two days under the hospital eye service. The patient was discharged to private consult and seen almost every day for six weeks. The optician? S report noted acanthamoeba and a left eye cornea scar with medical intervention, but does not relate details. Biomicroscopy and visual acuity exam were not performed because the patient was still under treatment. Follow-up information was requested but no further information was received as of the submission date of this report.
Patient Sequence No: 1, Text Type: D, B5
[21667565]
The complaint is unconfirmed. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614392-2013-00050 |
| MDR Report Key | 3525672 |
| Report Source | 05 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-19 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2013-11-19 |
| Date Added to Maude | 2013-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOE NESCI |
| Manufacturer Street | 6150 STONERIDGE MALL ROAD SUITE 370 |
| Manufacturer City | PLEASANTON CA 945883176 |
| Manufacturer Country | US |
| Manufacturer Postal | 945883176 |
| Manufacturer Phone | 9256213775 |
| Manufacturer G1 | COOPERVISION MANUFACTURING LIMITED |
| Manufacturer Street | HAMBLE LANE |
| Manufacturer City | HAMBLE, S0314RF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | S031 4RF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIONS MULTI SOLUTION |
| Generic Name | OPTHALMIC CONTACT LENS SOLUTION |
| Product Code | LYL |
| Date Received | 2013-12-18 |
| Lot Number | UKN |
| Operator | LAY USER/PATIENT |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION MANUFACTURING LIMITED |
| Manufacturer Address | HAMBLE LANE HAMBLE, S0314RF UK S031 4RF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-12-18 |