MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-19 for IMPLANTABLE MINIATURE TELESCOPE WA 2.7 X PR00020-00 manufactured by Visioncare Ophthalmic Technologies, Inc..
[20786084]
On (b)(6) 2014, a patient underwent telescope implantation for end-stage macular degeneration. On the day one postoperative exam, the physician reported that the patient notes haze. The cornea and rest of the eye is clear. The physician reported that the implant looks like it has "condensation" behind the front surface, something he also noticed early on during the surgery. At the day seven postoperative visit, the problem remained. Reference mfr # 3005347768-2014-00002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005251015-2014-00002 |
| MDR Report Key | 4349927 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-11-23 |
| Date Facility Aware | 2014-10-23 |
| Report Date | 2014-11-19 |
| Date Reported to FDA | 2014-11-19 |
| Date Reported to Mfgr | 2014-10-23 |
| Date Added to Maude | 2014-12-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Manufacturer Street | 14395 SARATOGA AVE. SUITE 150 |
| Manufacturer City | SARATOGA CA 95070 |
| Manufacturer Country | US |
| Manufacturer Postal | 95070 |
| Manufacturer G1 | VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. |
| Manufacturer Street | 14395 SARATOGA AVE. SUITE 150 |
| Manufacturer City | SARATOGA CA 95070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95070 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE MINIATURE TELESCOPE |
| Generic Name | TELESCOPE IMPLANTABLE MINIATURE |
| Product Code | NCJ |
| Date Received | 2014-11-19 |
| Model Number | WA 2.7 X |
| Catalog Number | PR00020-00 |
| Lot Number | 10506 |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 30 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. |
| Manufacturer Address | PETAH TIKVA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-19 |