MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-16 for CVUE MULTIFOCAL CONTACT LENS manufactured by Unilens Corp., Usa.
[1958599]
The patient is a contact lens user, and felt there was something on the lens when first used out of the package, but used the lens anyway due to lack of time. After one hour, the patient had a significant foreign body sensation with blurry vision, and removed the lens within 3 hours. On (b)(6) patient presented to the eyecare practitioner with an infection in the right eye, and presented to an ophthalmologist on (b)(6). The infection was described as possibly (b)(6); a culture taken was (b)(6). The treatment was a prophylactic antibiotic and bandage contact lens, adding a cycloplegic agent for comfort with oral antiviral agent and oral painkiller. The visual prognosis is good.
Patient Sequence No: 1, Text Type: D, B5
[9160486]
No device was returned for evaluation. The account indicated that the lot number of the dispensed product was not recorded. Review of account and patient records isolated four possible lots that the product could be from r86014911, r86021108, r06029906, and r06009015. Of the four lots, two lots (r06029906 and r06009015) have available inventory that was examined for package integrity and sterility. Sterility testing on samples of these two lots will be concluded the week of (b)(4) 2011. The contract manufacturer of the product has been contacted and is performing lot history reviews of the processing of the four suspect lots for sterilization effectiveness and other reports of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034196-2011-00001 |
| MDR Report Key | 2031299 |
| Report Source | 05 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-02-19 |
| Date Mfgr Received | 2011-03-02 |
| Date Added to Maude | 2011-04-27 |
| 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 | ALAN FRAZER, DIRECTOR |
| Manufacturer Street | 10431 72ND ST. NORTH |
| Manufacturer City | LARGO FL 33777 |
| Manufacturer Country | US |
| Manufacturer Postal | 33777 |
| Manufacturer Phone | 7275442531 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVUE MULTIFOCAL CONTACT LENS |
| Generic Name | SOFT CONTACT LENS |
| Product Code | HPX |
| Date Received | 2011-03-16 |
| Model Number | CVUE MULTIFOCAL |
| Lot Number | UNK |
| ID Number | 8.8 14.5 LOW ADD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNILENS CORP., USA |
| Manufacturer Address | LARGO FL 33777 US 33777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-16 |