CATALYS SYSTEM CAT PREC LSR SYSRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474617186), received between Sep 9, 2019 and Sep 23, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  During surgery performed with the Catalys System on (b)(6) 2026, the patient experienced a stromal extrusion at the primary incision of the left eye (OS). The issue was identified at a postoperative visit on (b)(6) 2026, and a bandage contact lens was applied. No further information was provided.

  Patient problems: Eye Injury

  MAUDE report 50872135 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATALYS PROCEDURE WAS COMPLETED SUCCESSFULLY. DURING THE SUBSEQUENT CATARACT SURGERY IN THE OPERATING ROOM, A POSTERIOR CAPSULE TEAR WAS IDENTIFIED INTRAOPERATIVELY DURING PHACOEMULSIFICATION. AS A RESULT, A PORTION OF THE LENS NUCLEUS FELL INTO THE POSTERIOR CHAMBER. THE ANTERIOR CAPSULE AND THE CAPSULORHEXIS WERE REPORTED TO BE INTACT. DOCTOR USED A DIFFERENT INTRAOCULAR LENS THAN ORIGINALLY PLANNED AND IMPLANTED THE LENS IN THE SULCUS RATHER THAN IN THE CAPSULAR BAG. A VITRECTOMY WAS PERFORMED. THE PATIENT IS BEING REFERRED TO A RETINA SPECIALIST. THE PHYSICIAN STATED THAT THE POSTERIOR CAPSULE TEAR WAS NOT ATTRIBUTED TO THE CATALYS LASER AND WAS MOST LIKELY ASSOCIATED WITH HYDRODISSECTION OR THE PHACOEMULSIFICATION STEP OF THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25129423 ↗
• MalfunctionOct 24, 2025Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 13 MALFUNCTION EVENTS. THE EVENT WAS RELATED SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386199 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEY WERE INITIALLY UNABLE TO ENTER THE SIDE PORT INCISION AFTER USING THE CATALYS SYSTEM, THEN DISCOVERED THAT THE EIPERT FORCEP WAS BENT. PHYSICIAN SUCCESSFULLY ENTERED SIDE PORT WITH A SINSKI BUT WAS UNABLE TO FIND THE INCISION WITH A CANNULA, SO THEY USED A 1.0 MM BLADE TO OPEN THE INCISION. HE OPENED THE PRIMARY INCISION EASILY WITH A NEW EIPERT. AT THE END OF THE CASE, THE PRIMARY INCISION LEAKED, NECESSITATING SUTURES, WHICH THE PHYSICIAN ATTRIBUTED TO A POSSIBLE 'WOUND BURN' FROM PHACO (CENTURION). HE ALSO FACED INITIAL OCCLUSION AND FOOT PEDAL CONNECTION ISSUES WITH THE CENTURION PHACO MACHINE. DESPITE THESE CHALLENGES, THE SIDE PORT INCISION SELF-SEALED, AND THE CATARACT SURGERY AND IOL IMPLANT WERE SUCCESSFULLY COMPLETED WITHOUT FURTHER SURGICAL INTERVENTION OR HARM TO THE PATIENT. THE CAPSULOTOMY WAS COMPLETED AND HE LIKED THE LENS SOFTENING. APPLICATION SUPPORT MANAGER (ASM) DISCUSSED CATARACT INCISION GEOMETRY WITH DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence

  MAUDE report 21139171 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SMALL RADIAL TEAR WHILE USING THE CATALYS SYSTEM. AN INTRAOCULAR LENS (IOL) WAS PLACED HOWEVER, PATIENT HAD TO RETURN BACK TO SURGERY AS THE IOL ROTATED AND HAD TO BE EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE CATALYS SYSTEM. A SEPARATE WILL BE FILED AGAINST THE IOL.

  Patient problems: Capsular Bag Tear

  MAUDE report 19986845 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PHACO SCULPTING IN THE OPERATING ROOM (OR), THE SURGEON EXPERIENCED A POSTERIOR CAPSULE RUPTURE IN THE RIGHT EYE, CAUSING THE SURGEON TO COMPLETE AN ANTERIOR VITRECTOMY. THE SURGEON PROCEEDED TO IMPLANT A SULCUS INTRAOCULAR LENS (IOL) AND REPORTED THAT THE PATIENT WILL BE REFERRED TO A SPECIALIST FOR A POSTERIOR VITRECTOMY. THE SURGEON MENTIONED THAT HE EXPECTS THE PATIENT TO HAVE A GOOD VISUAL OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19052680 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PHACO SCULPTING IN THE OPERATING ROOM (OR), THE SURGEON NOTICED A POSTERIOR CAPSULE TEAR, CAUSING THE SURGEON TO COMPLETE AN ANTERIOR VITRECTOMY. THE SURGEON PROCEEDED TO IMPLANT AN INTRAOCULAR LENS (IOL) AND EXPECTS VISION TO BE 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19047098 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, DOCTOR HAD TO PERFORM AN ANTERIOR VITRECTOMY (AFTER HYDRODISSECTION). CATARACT PROCEDURE WAS PARTIALLY COMPLETED AND AN IOL WAS INSERTED. SECONDARY INTERVENTION FROM RETINA WILL BE NEEDED AND DONE AT A LATER DATE TO REMOVE THE REST OF THE CATARACT. PER DOCTOR THIS WAS NOT RELATED TO THE CATALYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 16400828 ↗
• MalfunctionJan 23, 2023Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO LCS : DC-SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228332 ↗
• MalfunctionOct 29, 2022Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696018 ↗
• MalfunctionApr 29, 2022Decrease in Suction; Decrease in Suction

  THIS SUMMARY REPORT IS FOR 1 MALFUNCTION EVENT. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251907 ↗
• MalfunctionFeb 5, 2021Decrease in Suction; Decrease in Suction

  SUCTION LOSS AFTER LASER FIRING WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE CATALYS LASER PROCEDURE ON (B)(6) 2020, SUCTION WAS LOST DURING THE LASER FIRING PORTION OF THE PROCEDURE. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11285814 ↗
• MalfunctionJan 13, 2021Decrease in Suction; Suction Problem; Computer System Security Problem; Decrease in Suction; Suction Problem; Computer System Security Problem

  VACUUM LOSS AFTER LASER FIRING WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE CATALYS LASER PROCEDURE ON (B)(6) 2020, A CATALYS SYSTEM ERROR OCCURRED WITH 2 SECONDS LEFT IN THE TREATMENT. THE VACUUM LOST OCCURRED BEFORE THE ERROR. THE TREATMENT STOPPED AND THEY WERE UNABLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168539 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT ZONULAR DEHISCENCE WAS IDENTIFIED HALFWAY THROUGH THE PHACO PORTION OF THE PROCEDURE. NUCLEAR LENS MATERIAL MIGRATED TO THE POSTERIOR CHAMBER. THE PROCEDURE WAS COMPLETED WITHOUT INTRA OCULAR LENS (IOL) IMPLANTATION. THE SURGEON STATED THAT THE PATIENT HAD A DENSE BRUNESCENT CATARACT. THE SURGEON ALSO REPORTED THAT THE OUTCOME WAS RELATED TO THE PATIENT¿S ANATOMY AND WAS NOT A COMPLICATION DUE TO THE CATALYS TREATMENT. THE PATIENT WAS REFERRED FOR RETINAL CONSULTATION FOR RETAINED LENS NUCLEUS.

  Patient problems: No Code Available

  MAUDE report 8974355 ↗