MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for C-VUE CVUE GP +6.25, 8.54, 9.8 manufactured by Unilens Corp., Usa.
[597466]
On 26 mar 2007, notified by sales rep that eye clinic had a pt report a cvue gp contact lens broke in the eye, and was treated at the er. When contacted later in the day, the contact lens associate reviewed the er report: on saturday morning, the pt noted his right eye began to hurt, and could not remove his contact. He presented at the er and was see by an attending physician. Only one portion of the lens remained in the eye, and after searching and flushing the eye, the remaining portion was retrieved. The pt was diagnosed with a corneal abrasion, was provided with vigamox antibiotic for application 3x daily, instructed to leave his lenses out and to see his eyecare practitioner on monday. The pt's visual acuity with spectacle correction was 20/60 in the right eye at the conclusion of the er visit. Three days later,advised by a phone mail that the pt had seen the eyecare practitioner and the eye was found in excellent condition with no residual effect.
Patient Sequence No: 1, Text Type: D, B5
[7924588]
Eval of the returned portion of the lens was inconclusive. The nature of the fracture as seen under visible and polarized light was of a propagated fracture across the optic, with no apparent stress fractures indicating a point of impact or damage. No conclusions can be drawn concerning the damage that occurred to the lens to cause it to break into pieces.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034196-2007-00001 |
| MDR Report Key | 839963 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-12 |
| Date of Event | 2007-03-24 |
| Date Mfgr Received | 2007-03-26 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-04-24 |
| 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, DIR |
| 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 | C-VUE |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 2007-04-12 |
| Returned To Mfg | 2007-04-10 |
| Model Number | CVUE GP |
| Catalog Number | +6.25, 8.54, 9.8 |
| Lot Number | 907107 |
| ID Number | FL30 BL |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 827249 |
| Manufacturer | UNILENS CORP., USA |
| Manufacturer Address | * LARGO FL 33777 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-12 |