| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OMNI LUMERA 700 | MICROSCOPE, OPHTHALMIC, OPERATING ... | CARL ZEISS MEDITEC AG | EPT | 700 | 305953-9900-000 | NA | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-12-10 | 0 | 1. O |
Patient 1
THE XENON LAMP OF THE OPMI LUMERA 700 MICROSCOPE WENT OUT TWICE DURING AN OPHTHALMIC SURGERY. THE SURGEON REMOVED THE INSTRUMENTS FROM THE PATIENT'S EYE WHEN THE LIGHT WENT OUT AND CONTINUED THE SURGERY WHEN THE LIGHT CAME BACK ON. THE SURGEON REPORTED THAT A POSTERIOR CAPSULAR BAG RUPTURE WAS NOTICED AFTER THE LIGHT CAME BACK ON FOR THE SECOND TIME. THE SURGEON MADE A DECISION TO IMPLANT AN ALTERNATIVE SULCUS IOL LENS WHICH CAN BE IMPLEMENTED WITHOUT A CAPSULAR BAG.
Patient 1
THE MANUFACTURER INSPECTED THE AFFECTED DEVICE AND COULD NOT REPRODUCE THE REPORTED LIGHT FAILURE WHEN SIMULATING POTENTIAL CUSTOMER LIGHT SCENARIOS. NO MALFUNCTION WAS FOUND AND THE DEVICE MEETS MANUFACTURER'S SPECIFICATION. THE USER MANUAL ADVISES TO PERFORM A COMPLETE FUNCTIONAL TEST PRIOR TO EACH SURGERY. THE MANUAL ALSO INFORMS ABOUT THE EASY OPTION OF SWITCHING TO THE BACKUP LAMP, WHICH WAS NO INTENDED IN THIS CASE. THE USER MANUAL ADVISES ALSO THAT THE CUSTOMER HAS TO HAVE AVAILABLE AN INDEPENDENT OPERATIONAL LAMP IN CASE THAT THE LIGHT SYSTEM OF THE MICROSCOPE WOULD FAIL.
Patient 1
THE HEALTH CARE PROFESSIONAL REPORTED: A SUBSEQUENT YAG LASER CAPSULOTOMY WAS PERFORMED TO ADDRESS CLOUDING OF THE REMAINING CAPSULE.