MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-13 for LABTICIAN, INC STYLE #276 * manufactured by Labtician Ophthalmics, Inc.
[253387]
Clinical summary: this is a pt two years post left eye surgery with pars planitis vitrectomy, scleral buckle, membrane peeling and external laser in 1999. The pt was examined for stability of the retinal attachment status at 6 months, 12 months, and 18 months thereafter. All 3 exams were unremarkable. In 2001 the pt began experiencing severe, constant headaches in left temple at the eye socket juncture and daily left eye discharge mixed with frank blood. Pt was seen in 2002 on consultation. After 6 weeks prescription with prophylactic ciloxan every day, clinical assessment revealed that the scleral buckle is working its way out of the eye tissue causing low grade infection and headaches. Early surgery for removal of this device was strongly indicated and recommended. Pt was informed that the procedure carries with it the risk of re-detachment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024321 |
| MDR Report Key | 381810 |
| Date Received | 2002-03-13 |
| Date of Report | 2002-03-13 |
| Date of Event | 2001-01-01 |
| Date Added to Maude | 2002-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABTICIAN, INC |
| Generic Name | SCLERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2002-03-13 |
| Model Number | STYLE #276 |
| Catalog Number | * |
| Lot Number | 12369 |
| ID Number | REF S 2999 |
| Device Expiration Date | 2006-08-01 |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 370857 |
| Manufacturer | LABTICIAN OPHTHALMICS, INC |
| Manufacturer Address | * OAKVILLE, ONTARIO CA |
| Brand Name | LABTICIAN, INC |
| Generic Name | SCLERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2002-03-13 |
| Model Number | STYLE #240 |
| Catalog Number | * |
| Lot Number | 12439 |
| ID Number | REF S 2967 |
| Device Expiration Date | 2006-08-01 |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 370859 |
| Manufacturer | LABTICIAN OPHTHALMICS, INC |
| Manufacturer Address | * OAKVILLE, ONTARIO CA |
| Brand Name | LABTICIAN, INC |
| Generic Name | SCLERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2002-03-13 |
| Model Number | STYLE #270 |
| Catalog Number | 83019 |
| Lot Number | 13667 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 3 |
| Device Event Key | 370860 |
| Manufacturer | LABTICIAN OPHTHALMICS, INC |
| Manufacturer Address | * OAKVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-03-13 |