| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPMI LUMERA T | SURGICAL MICROSCOPE | CARL ZEISS SURGICAL GMBH | EPT | 1493-090 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-06-25 | 0 | |
| 2 | 2009-06-25 | 0 |
Patient 1
TWO PATIENTS WERE REPORTED AS HAVING RETINAL DAMAGE AFTER UNDERGOING COMPLEX CATARACT SURGERY (CONGENITAL CATARACT AND ECTOPIA LENTIS CATARACT) AFTER APPROXIMATELY 1.5 HOURS. IN 2009, TWO ADDITIONAL PATIENTS WERE ALSO REPORTED AS HAVING RETINAL DAMAGE.
Patient 2
TWO PATIENTS WERE REPORTED AS HAVING RETINAL DAMAGE AFTER UNDERGOING COMPLEX CATARACT SURGERY (CONGENITAL CATARACT AND ECTOPIA LENTIS CATARACT) AFTER APPROXIMATELY 1.5 HOURS. IN 2009, TWO ADDITIONAL PATIENTS WERE ALSO REPORTED AS HAVING RETINAL DAMAGE.
Patient 1
THE DEVICE WAS INSPECTED ON SITE AT THE CUSTOMER'S LOCATION AND FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE WAS CHECKED AGAIN AT THE MANUFACTURER'S LOCATION AND FOUND TO BE WITHIN SPECIFICATIONS. NO MALFUNCTION OF THE DEVICE WAS DETECTED DURING EITHER INSPECTION. THE DEVICE WAS USED FOR COMPLEX CATARACT SURGERIES FOR AN EXTENDED PERIOD OF TIME. ANALYSIS OF THE PATIENT DATA INDICATES THAT CATARACT SURGERY LASTED UP TO 1.5 HOURS WITHOUT THE OPERATOR USING ANY OF THE PROTECTION MECHANISMS INSTALLED IN THE DEVICE. THE "SAFETY" SECTION OF THE USER MANUAL (PAGES 23-30) PROVIDES THE USER WITH INFORMATION CONCERNING THE RISK OF PHOTOTOXIC RETINAL INJURY IN EYE SURGERY. THE USER MANUAL PROVIDES INFORMATION ON THE PROTECTION MECHANISMS INSTALLED IN THE DEVICE, RECOMMENDATIONS FOR MINIMIZING PHOTOTOXIC RISK, AND MAXIMUM RADIATION EXPOSURE TIMES.
Patient 2
THE DEVICE WAS INSPECTED ON SITE AT THE CUSTOMER'S LOCATION AND FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE WAS CHECKED AGAIN AT THE MANUFACTURER'S LOCATION AND FOUND TO BE WITHIN SPECIFICATIONS. NO MALFUNCTION OF THE DEVICE WAS DETECTED DURING EITHER INSPECTION. THE DEVICE WAS USED FOR COMPLEX CATARACT SURGERIES FOR AN EXTENDED PERIOD OF TIME. ANALYSIS OF THE PATIENT DATA INDICATES THAT CATARACT SURGERY LASTED UP TO 1.5 HOURS WITHOUT THE OPERATOR USING ANY OF THE PROTECTION MECHANISMS INSTALLED IN THE DEVICE. THE "SAFETY" SECTION OF THE USER MANUAL (PAGES 23-30) PROVIDES THE USER WITH INFORMATION CONCERNING THE RISK OF PHOTOTOXIC RETINAL INJURY IN EYE SURGERY. THE USER MANUAL PROVIDES INFORMATION ON THE PROTECTION MECHANISMS INSTALLED IN THE DEVICE, RECOMMENDATIONS FOR MINIMIZING PHOTOTOXIC RISK, AND MAXIMUM RADIATION EXPOSURE TIMES.