MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2006-03-13 for STRATUS OCT 3000 * manufactured by Carl Zeiss Meditec, Inc..
[468487]
Patient underwent routine eye examinations for glaucoma, including stratus oct imaging. While undergoing the procedure,the patient complained of being bothered by the bright light emitted by the instrument during scanning. Shortly thereafter , patient had an episode of seizure described as disorientation, unresponsiveness, and muscle contractions without tongue biting and incontinence lasting approximately 45 seconds. Upon examination by a paramedic, patient was taken to an emergency room for further care. No untoward sequelae were noted after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2006-00001 |
| MDR Report Key | 688841 |
| Report Source | 06,08 |
| Date Received | 2006-03-13 |
| Date of Report | 2006-03-09 |
| Date of Event | 2006-02-14 |
| Date Mfgr Received | 2006-02-16 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-03-20 |
| 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 | KENT JONES |
| Manufacturer Street | 5160 HACIENDA DR |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574353 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUS OCT |
| Generic Name | OPTICAL COHERENCE TOMOGRAPHY SCANNER |
| Product Code | HLI |
| Date Received | 2006-03-13 |
| Model Number | 3000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 678044 |
| Manufacturer | CARL ZEISS MEDITEC, INC. |
| Manufacturer Address | * DUBLIN CA * US |
| Baseline Brand Name | STRATUS OCT |
| Baseline Generic Name | OPTICAL CORNEAL TOMOGRAPHY |
| Baseline Model No | 3000 |
| Baseline Catalog No | 00203-01 |
| Baseline Device Family | OCT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K030433 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-13 |