MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-29 for QUANTUM THIN HIGH ADD RGP MULTIFOCAL NA manufactured by Unilens Corp., Usa.
[14872423]
Documentation received with returned product indicated "this lens is defective. Abrasion 2009 rec'd new cl". The following month, the attending healthcare practitioner responded to queries and indicated the abrasion was noted at the time of contact lens dispensing, with the lens being too uncomfortable and painful for the patient. Prophylactic antibiotics were given. No prognosis was given. The pt is not currently wearing a replacement contact lens. No solutions were dispensed to the pt, and the pt is using a deep well screw top contact lens container.
Patient Sequence No: 1, Text Type: D, B5
[15453876]
All tested parameters met inspection/release criteria for the returned lens. In the cosmetic examination of the lens surfaces, a small burnished area was found near the edge of the lens that was within acceptable criteria and would not have caused the noted adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034196-2009-00001 |
| MDR Report Key | 1373506 |
| Report Source | 05 |
| Date Received | 2009-04-29 |
| Date of Report | 2009-04-29 |
| Date Mfgr Received | 2009-03-31 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2009-05-07 |
| 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 | 3 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM THIN HIGH ADD RGP MULTIFOCAL |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 2009-04-29 |
| Returned To Mfg | 2009-03-31 |
| Model Number | QUANTUM THIN |
| Catalog Number | NA |
| Lot Number | 231093 |
| ID Number | 7.35 9.2 -8.25 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-04-29 |