MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-13 for C-VUE CVUE GP -3.62, 7.71BC, 9.8MM manufactured by Unilens Corp., Usa.
[622179]
On 13 june 2007, notified by sales rep that sapula vision, sapula ok, had a patient report a cvue gp contact lens broke in the eye, and was treated at the emergency room. The physician was contacted 14 june and had no further information, as he had not seen the patient. No further information has been provided after repeated contact with the eyecare practitioner.
Patient Sequence No: 1, Text Type: D, B5
[7968141]
Method - mfg records were examined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034196-2007-00002 |
| MDR Report Key | 880626 |
| Report Source | 05 |
| Date Received | 2007-07-13 |
| Date of Report | 2007-07-13 |
| Date of Event | 2007-06-13 |
| Date Mfgr Received | 2007-06-13 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-11-15 |
| 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 |
| 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 | C-VUE |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 2007-07-13 |
| Model Number | CVUE GP |
| Catalog Number | -3.62, 7.71BC, 9.8MM |
| Lot Number | 909705 |
| ID Number | FL30 BL |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 915312 |
| Manufacturer | UNILENS CORP., USA |
| Manufacturer Address | LARGO FL 33777 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-13 |