QUATERA 700 BIMANUAL I/A HANDPIECE SET

Additional Manufacturer Narrative

DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 02/26/2024. FIELD D9: CHECKED "YES", CHECKED "REURNED TO MANUFACTURER". FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "DEVICE EVALUATION" FIELD H3: UPDATED "DEVICE EVALUATED BY MANUFACTURER?" TO "YES". FIELD H6: ADDED "TYPE OF INVESTIGATION" CODE 10. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHEMENTS: ATTACHED DEVICE EVALUATION.

Additional Manufacturer Narrative

DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 01/06/2025. FIELD G3: ADDED "DATE RECEIVED BY MANUFACTURER" 12/20/2024. FIELD G4: CORRECTED "PMA/510(K) NUMBER" FROM "K130549" TO "K212241". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 2". FIELD H2: CHECKED "CORRECTION". FIELD H11: ADDED DESCRIPTION OF CHANGES.

Description of Event or Problem

ON (B)(6) 2023, A DOCTOR REPORTED THAT HE EXPERIENCED A COMPLICATION WITH THE BI-MANUAL I/A SET DURING A REFRACTIVE LENS EXCHANGE ON (B)(6) 2023. THE DOCTOR MENTIONED HE OPENED THE SET TO USE DURING CORTEX, AND DIDN'T REALIZE THAT THE PACKAGE INCLUDED TWO ASPIRATION HAND-PIECES AND NOT AN IRRIGATOR. HE HAS NOT SEEN THIS BEFORE AND DID NOT EXPECT IT. HE THEN ENGAGED THE LENS CORTEX, THE SECOND ASPIRATION PORT ASPIRATED THE POSTERIOR CAPSULE CAUSING A RUPTURE. FORTUNATELY THE HYALOID FACE WAS INTACT. A 3-PIECE LIGHT ADJUSTABLE LENS WAS PLACED IN THE SULCUS WITH OPTIC CAPTURE. THE PATIENT WAS SEEING WELL AT THE POST-OP VISIT.

Additional Manufacturer Narrative

THE BI-MANUAL I/A SET IS SINGLE-USE ACCESSORY OF THE QUATERA 700 DEVICE.