QUATERA 700

Additional Manufacturer Narrative

THE DESCRIBED ISSUE AND POTENTIAL ROOT CAUSES HAVE BEEN ANALYZED COMPREHENSIVELY. THE MANUFACTURER'S R&D WAS NOT ABLE TO REPRODUCE THE ERRONEOUS BEHAVIOR AND DID NOT FIND A SYSTEMATIC MALFUNCTION OF ANY INVOLVED INSTRUMENTS OR THE OF THE RESPECTIVE DEVICE. THE ROOT CAUSE CAN BE MANIFOLD AND/OR A COMBINATION OF THINGS, INCLUDING DEVICE, SURGERY SETTING, USAGE, AND INSTRUMENT ABNORMALITIES. DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 05/13/2025. FIELD D9: UPDATED TO "NO." FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO 6/3/2025". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1." FIELD H2: CHECKED "ADDITIONAL INFORMATION." FIELD H3: UPDATED TO "NO." FIELD H6: ADDED CODES - 4105, 4103, AND 4112 FOR TYPE OF INVESTIGATION. 213 FOR INVESTIGATION FINDINGS. 67 AND 4315 FOR INVESTIGATION FINDINGS. FIELD H11: ADDED DESCRIPTION OF CHANGES.

Description of Event or Problem

A CUSTOMER IN AUSTRALIA REPORTED EXPERIENCING SIGNIFICANT POSTERIOR PRESSURE INSTABILITY DURING SURGERY WITH THE QUATERA 700 WHILE ATTEMPTING TO REMOVE THE LAST QUADRANT IN QUAD MODE. THE SURGEON INDICATED THAT HE COULD NOT PREVENT A LARGE SURGE, WHICH RESULTED IN A POSTERIOR CAPSULE (PC) TEAR. ADDITIONALLY, THE ANTERIOR CHAMBER (AC) BECAME FLAT, AND THE INSTABILITY WAS MORE PRONOUNCED WITH A SHALLOW AC DEPTH. THE ORIGINALLY PLANNED LENS WAS A MONOFOCAL LENS; HOWEVER, FOLLOWING THE TEAR, THE SURGEON HAD TO USE A THREE-PIECE SULCUS LENS. FORTUNATELY, THE PATIENT'S VISION IS GOOD, AND NO FURTHER MEDICAL INTERVENTION IS REQUIRED.