MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-02-23 for UNILENS RGP ASPHERE UNILESN RGP ASPHERE * manufactured by Unilens Corp., Usa.
[19242743]
In 2006, subject's eye began to feel uncomfortable, so subject removed lens, but it came out in pieces. Subject called physician who recommended presenting at the local hosp emergency room. The subject was seen at the emergency room, the eye examined, eyedrops were prescribed (tombramycin atnibiotic), a tetnaus shot was administered, and the pt discharged. The diagnostic at the emergency room was a corneal abrasion at 9 o'clock and a second lesser corneal abrasion at 6 o'clock. The subject contacted the manufacturer when she was unable to contact her eye care professional. She was advised to follow the care instructions from the emergency room and continue to contact her eyecare professional. She felt her eye was 'better' at that time. The subject's eyecare professional was contacted by the manufacturer and was requested to provide a prognosis whent he pt could be seen. As of 23 feb 2006, the pt had not returned to the eyecare professional's office due to lingering family illness. No results have been forwarded from the eyecare professional to the manufacturer at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034196-2006-00001 |
| MDR Report Key | 681006 |
| Report Source | 04 |
| Date Received | 2006-02-23 |
| Date of Report | 2006-02-23 |
| Date of Event | 2006-01-24 |
| Date Mfgr Received | 2006-01-25 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-03-03 |
| 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 STREET NORTH |
| Manufacturer City | LARGO FL 33777 |
| Manufacturer Country | US |
| Manufacturer Postal | 33777 |
| Manufacturer Phone | 7275442531 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNILENS RGP ASPHERE |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 2006-02-23 |
| Model Number | UNILESN RGP ASPHERE |
| Catalog Number | * |
| Lot Number | 700932 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670277 |
| Manufacturer | UNILENS CORP., USA |
| Manufacturer Address | * LARGO FL 33777 US |
| Baseline Brand Name | UNILENS RGP ASPHERE |
| Baseline Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Baseline Model No | UNILESN RGP ASP |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-23 |