| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE | OPHTHALMIC HOOK | IANTECH, INC. | HNQ | FG-11881 | FG20170516-01 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-01-23 | 0 | 1. R |
Patient 1
THE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT NUMBER AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE PATIENT'S PREEXISTING ADVANCED CATARACT WAS A SIGNIFICANT CONTRIBUTING FACTOR AND THERE WAS NO REPORT OF A DEVICE MALFUNCTION. CAPSULAR BAG DAMAGE AND VITREOUS LOSS ARE INHERENT RISKS OF CATARACT SURGERY. MANUFACTURER'S REFERENCE #: (B)(4).
Patient 1
A PATIENT WITH A DENSE 4+ BRUNESCENT CATARACT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2017 WHERE THE LEEP DEVICE WAS USED TO SECTION THE CATARACTOUS LENS INTO FRAGMENTS. AT SOME POINT DURING THE PHACOEMULSIFICATION PROCEDURE THE POSTERIOR CAPSULE TORE AND RESULTED IN VITREOUS LOSS. THE EVENT REQUIRED SECONDARY SURGICAL INTERVENTION TO PERFORM A VITRECTOMY AND INTRAOCULAR LENS (IOL) IMPLANTATION WAS DEFERRED FOR ONE WEEK WHEN A SCLERAL-FIXATED IOL WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE IMPACT ON THE PATIENT'S VISION AND NO SEQUELAE. THE SURGEON ATTRIBUTED THE EVENT TO THE PATIENT'S ADVANCED CATARACT. THE PATIENT WAS EXAMINED 3 MONTHS POSTOPERATIVELY AND THE PATIENT WAS DOING WELL WITH IMPROVED VISION.