MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-25 for UNILENS QUANTUM THIN manufactured by Unilens Corp., Usa.
[846027]
Patient presented to eye care practitioner with pain and photophobia in left eye on (b) (6) 2008. Diagnosed as corneal abrasion caused by defective contact lens. Patient was provided with a hydrogel (soft) bandage contact lens. Patient was seen (b) (6) 2008. Healing was progressing well; nearly complete, prognosis is complete recovery with ability to wear contacts again. Patient was subsequently refitted with soft contact lenses since the abrasion healed completely. The primary eye care practitioner indicated the patient is unable to extract contacts from eyes with fingers, and must use a plunger. The practitioner suspects the means of lens extraction contributed to the injury. No lens has been returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[8019702]
Manufacturing records were examined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034196-2008-00001 |
| MDR Report Key | 1058152 |
| Report Source | 05 |
| Date Received | 2008-05-25 |
| Date of Report | 2008-05-23 |
| Date of Event | 2008-04-25 |
| Date Mfgr Received | 2008-04-28 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-04-06 |
| 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 Street | 10431 72ND STREET 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 | UNILENS QUANTUM THIN |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 2008-05-25 |
| Model Number | QUANTUM THIN |
| Lot Number | 129601 |
| 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. Required No Informationntervention | 2008-05-25 |