| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPMI LUMERA 700 | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY | CARL ZEISS MEDITEC AG (OBERKOCHEN) | HRM | NA | 305953-9900-000 | NA | N | * |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-16 | 0 | 1. O |
Patient 1
THE HEALTHCARE PROVIDER REPORTED FOLLOWING: THE LIGHT OF THE OPMI LUMERA 700 MICROSCOPE STARTED FLICKERING DURING AN OPHTHALMIC SURGERY. ALTHOUGH THE LIGHT INTENSITY WAS INCREASED THE SURGEON STILL DID NOT HAVE A CLEAR VIEW. AT THIS STAGE A CENTRAL POSTERIOR CAPSULAR HOLE WAS NOTED. THE SITE DETERMINED THAT THE PHACO TIP HAD GONE THROUGH THE POSTERIOR CAPSULE DUE TO AN UNCLEAR VIEW.
Patient 1
MANUFACTURER NARRATIVE: THE DISTRIBUTOR'S FIELD SERVICE ENGINEER WENT ONSITE AND WAS ABLE TO REPRODUCE THE LIGHT FLICKERING. HE MADE A VIDEO AND SENT IT TO THE MANUFACTURER. THE MANUFACTURER EVALUATED THE VIDEO AND CONFIRMED THAT THIS LIGHT FLICKERING IS NOT PART OF THE NORMAL BEHAVIOR OF XENON LIGHT BULBS. EVEN THE FLICKERING WAS VISIBLE, THE MANUFACTURER CONCLUDED THAT THE BRIGHT TO DARK VARIATION SEEN ON THE VIDEO WOULD NOT IMPACT ADVERSELY THE SURGEON'S VISIBILITY OR WORK. THE MOST LIKELY ROOT CAUSE COULD BE AN ISSUE WITH THE ATTENUATOR WHEEL OF THE LAMP CONTROL BOARD. THE DISTRIBUTOR DISCARDED THE RELATED PARTS, WHY A FINAL ROOT CAUSE CONCLUSION IS NOT POSSIBLE. THE USER MANUAL G-30-1673-EN DESCRIBES HOW TO HANDLE DIFFERENT ILLUMINATION ISSUES DURING SURGERY AND ADVISES ON PAGE 245: "IF THE BACKUP LAMP IS DEFECTIVE AND REPLACEMENT IS NOT POSSIBLE, CONTINUE SURGERY USING AN EXTERNAL OR ILLUMINATOR.". DEVICE EVALUATED BY MANUFACTURER. (B)(4).