LENSAR LLS-fs 3D 70-00013-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00867744000112), received between Oct 31, 2018 and Apr 28, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2025, WHILE CAS WAS ONSITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THEY HAD EXPERIENCED AN ANTERIOR CAPSULAR RENT AT TEMPORAL TORIC NUB DURING PROCEDURE ID #(B)(6). SITE IS SEEKING REVIEW OF THE PROCEDURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21919716 ↗
• InjuryDec 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 11/29/2024, (B)(6) SURGEON REPORTED TO LENSAR CUSTOMER SERVICE THAT ON (B)(6) 2024, CASE: (B)(4), HE EXPERIENCED A POSTERIOR RUPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20966072 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06/27/2024, IT WAS REPORTED TO LENSAR CUSTOMER SERVICE THAT DR. (B)(6) HAD CAPSULE RUPTURE ON PATIENT ID (B)(6) ON (B)(6) 2024. THE BRAKE WAS RIGHT AFTER LENSAR TREATMENT, AND HE HAD TO IMPLANT THE IOL INTO THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 19792204 ↗
• InjuryMar 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  P1008 - N/A ISSUE: ON 02/28/2024, IT WAS REPORTED TO CUSTOMER SERVICE THAT DR. (B)(6) REPORTED THAT ON (B)(6) 2024 HE HAD A POSTERIOR CAPSULAR RUPTURE ON PROCEDURE 538. HE COULD NOT USE A NORMAL IOL, HE HAD TO USE A SULCUS IOL.

  Patient problems: Capsular Bag Tear

  MAUDE report 19000144 ↗
• InjuryMar 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  P1008 - ANTERIOR CAPSULAR TEAR ISSUE: ON 02/21/2024, THAT THE DOCTOR AT SYSTEM LLS5158 REPORTED ANTERIOR CAPSULAR TEARS ON 3 PATIENTS. PATIENT (B)(6) ON (B)(6) 2024, PATIENT ID (B)(6) ON (B)(6) 2024 AND PATIENT ID (B)(6) ON (B)(6) 2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 18951932 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  P1008 - N/A ISSUE: ON (B)(6) 2024, (B)(6) REPORTED TO CUSTOMER SERVICE THAT DR(B)(6) REPORTED TO HIM THAT HE HAD A CAPSULE RUPTURE TODAY ON PROCEDURE 501.

  Patient problems: Capsular Bag Tear

  MAUDE report 18714312 ↗
• InjuryAug 24, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, DR. NOTIFIED CAS AND INDICATED THAT THEY HAD AN ISSUE WITH THE ASTIGMATIC OUTCOME ON APATIENT AND BELIEVE THAT IT WAS RELATED TO THE BED ORIENTATION.

  Patient problems: Insufficient Information

  MAUDE report 17611944 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE ID (B)(4). DURING CORTEX REMOVAL AFTER (B)(4) DR. NOTED A FRAGMENTATION IMPRINT ON THE CORTEX. WHEN SHE PULLED THE FIRST PIECE OF CORTEX WITH IA THE VITREOUS CAME INTO THE ANTERIOR CHAMBER AND THERE APPEARED TO BE NO POSTERIOR CAPSULE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A 3 PIECE IOL WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 16829668 ↗
• InjuryApr 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  P1008 - POSTERIOR CAPSULE TEAR - ISSUE: ON 03/20/2023 WHILE ON SITE, (LLS5124) THERE WAS A POSTERIOR CAPSULE TEAR ON LAST QUADRANT OF CATARACT REMOVED DURING PROCEDURE ID 715.

  Patient problems: Capsular Bag Tear

  MAUDE report 16751844 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ISSUE: ON (B)(6) 2022, ((B)(4)) REPORTED TO (B)(6) THAT "DR. (B)(6) FEELS LIKE HIS ARCUATE INCISION MAY HAVE PERFORATED AND HE WOULD LIKE THE CASE REVIEWED." DR. (B)(6) SUTURED THE AK AND PROCEEDED WITH NO COMPLICATIONS.

  Patient problems: Capsular Bag Tear

  MAUDE report 15797280 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). ANTERIOR CAPSULAR RADIAL TEAR - ISSUE: ON (B)(6) 2022 (B)(6) ON SITE AT (B)(4) FOR SURGEON TRAINING WITH DR. (B)(6). A TAGDEFENDER WAS NOTED PRIOR TO TREATMENT ON CASE #182. TAG DEFENDER WAS ACKNOWLEDGED, AND (B)(6) EXPLAINED THE OPTIONS. DR. (B)(6) PROCEEDED TO TREAT. THE CAPSULOTOMY WAS COMPLETED ABOUT 90 % AROUND EXCEPT 10 DEGREES INFERIOR. AT THE MICROSCOPE IT WAS NOTED BY THE SURGEON THE CORNEA HAD SOME TEAR FILM IRREGULARITY INFERIORLY AT THE SITE OF THE INCOMPLETE CAPSULOTOMY. DR (B)(6) PROCEEDED TO FINISH THE CAPSULOTOMY MANUALLY AND HAD A RADIAL RUNOUT TO THE PERIPHERY. HIS VIEW WAS LIMITED BY THE TEAR FILM AND SURFACEIRREGULARITY. DURING THE IA THE TEAR EXTENDED TO POSTERIOR. DR (B)(6) COMPLETED A BRIEF ANTERIOR VIT AND IMPLANTED A SULCUS LENS SUCCESSFULLY.

  Patient problems: Capsular Bag Tear

  MAUDE report 15695501 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  P1008 - CLINICAL OUTCOME - ISSUE: ON (B)(6) 2022, DR. (B)(6) (B)(4) REPORTED TO (B)(6) VIA EMAIL STATING "MY PATIENT NEEDED A TORICIOL, SO I USED LENSAR FOR THE CAP, 3-PLANE CHOP, AND INTELLIAXIS. THE CAP CAME OFF EASILY, AND THE INTELLIAXIS NUBS APPEARED NORMAL. I DID NOTICE THAT THE CHOP EXTENDED PRETTY DEEP SO THE PIE PIECES SEPARATED VIRTUALLY TO THE CAPSULE. AFTER REMOVING THE 6 PIECES OF NUCLEUS, I SAW A CLEAR LINEPOSTERIORLY IN CORTEX. I INJECTED VISCOAT BUT COULDN'T TELL WHETHER THE POSTERIOR CAPSULE HAD RUPTURED. I PROCEEDED TO I/A THE CORTEX AND SAW ANANTERIOR CAPSULE RENT EMANATING FROM THE INTELLIAXIS NUB. I THEN REALIZED THAT THE RENT HAD EXTENDED POSTERIORLY. NEEDLESS TO SAY, THIS WAS NOT MUCH FUN SINCE THE RENT OCCURRED WITH AN EYE FULL OF CORTEX. BUT, USING THE VITRECTOR I REMOVED THE CORTEX BUT HAD TO BAIL ON THE TORIC LENS SINCE THE LENS NEEDED SULCUS FIXATION."

  Patient problems: Capsular Bag Tear

  MAUDE report 15083274 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ISSUE: ON (B)(6) 2022, (B)(6) ((B)(4)) REPORTED TO (B)(6) THAT DR. (B)(6) HAD A WHAT APPEARED TO BE A "VERY LARGE BUBBLE" (B)(4). (B)(6) STATED THAT THE BAG COLLAPSED AS SOON AS DR. (B)(6) WENT INTO THE EYE. SITE IS REQUESTING THAT THE CASE BE REVIEWED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14218570 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  P1008 - POSTERIOR TEARSISSUE: DR. (B)(6) FROM (B)(6) CENTER (B)(4) REPORTED TO (B)(6) FROM (B)(6) REPORTED TO (B)(6) ON 02/07/2022 THAT ON (B)(6) 2022 TWO CASES HAD IRREGULAR CAPS BOTH CASES HAD POSTERIOR TEARSRESULTING IN VITRECTOMY. PATIENT ID (B)(6) AND (B)(6) . THE SITE WAS CLOSED DOWN DUE TO WEATHER AND REPORTED THE ISSUE TODAY.

  Patient problems: Capsular Bag Tear

  MAUDE report 13602508 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) REPORTED TO CUSTOMER SERVICE ON 01/27/2022 THAT DR. (B)(6) FROM (B)(4) HAD A BROKEN CAPSULAR NASAL TODAY. ACTION: LOG FILES WERE SENT IN FOR REVIEW. (B)(6) WOULD LIKE TO KNOW THE FINDINGS.

  Patient problems: Capsular Bag Tear

  MAUDE report 13584835 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/3/2019, LENSAR (B)(4) REPORTED THE FOLLOWING FROM A (B)(6) 2019 CASE DAY: "WHILE ON-SITE, THE DOCTOR REPORTED THAT HE HAD A PATIENT THAT RESULTED IN A DOUBLE-CUT (WISP) NEAR ONE INTELLI-L MARK, AND AN ANTERIOR TEAR AT THE OTHER MARK LOCATION. THE PATIENT WAS IMPLANTED WITH THE ORIGINALLY INTENDED IOL, AND THERE WERE NO COMPLICATIONS. NO SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Information

  MAUDE report 9269017 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/3/2019, LENSAR CAS REPORTED THE FOLLOWING FOR A (B)(6) 2019 CASE DAY: "WHILE ON-SITE, THE DOCTOR POINTED OUT A DOUBLE CUT (WISP) AND A SMALL ANTERIOR TEAR (NASAL SIDE) ON A PATIENT. NO COMPLICATIONS OCCURRED, AND THE PLANNED IOL WAS IMPLANTED. NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Information

  MAUDE report 9269016 ↗
• InjuryOct 31, 2018Off-Label Use; Off-Label Use

  ON 10/05/2018, LENSAR REPRESENTATIVE REPORTED THAT THE DOCTOR HAD A PROCEDURE IN WHICH THE CAPSULOTOMY WAS MADE IN THE MIDDLE OF THE LENS AND THE CHOP ABLATED ON THE POSTERIOR LENS. ACCORDING TO THE SURGEON, THE PATIENT HAD ICL (STAAR) IN HIS EYE AND THE SURGEON REMOVED ICL FROM HIS EYE TO DO A CATARACT SURGERY. ACCORDING TO THE CLINICAL APPLICATION STAFF, THE SCAN PROCEDURE WAS SUCCESSFUL AND IRIS REGISTRATION FAILED. NO MESSAGE WAS SHOWED DURING THE SURGERY.

  Patient problems: No Information

  MAUDE report 8023743 ↗