RxSight Light Adjustable Lens (RxLAL) 60005-3220Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00818806020715), received between Feb 2, 2022 and Sep 19, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2026Insufficient Device Problem Information

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50831677 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50262373 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO BLURRY DISTANCE VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 25480553 ↗
• InjuryMay 7, 2026Appropriate Device Problem Term/Code Not Available

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED. THE REASON FOR EXPLANT WAS REPORTED TO BE DUE TO A LACK OF REFRACTIVE ERROR CORRECTION AFTER LIGHT TREATMENTS. HOWEVER, LDD DATA REVIEWED BY RXSIGHT SUGGESTS REFRACTIVE CORRECTION WAS ACHIEVED FOR THIS LAL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25119790 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL). A VITRECTOMY WAS PERFORMED AND THE LAL OPTIC WAS PLACED IN THE BAG.

  Patient problems: Capsular Bag Tear

  MAUDE report 25089207 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24916744 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH NEAR VISION AFTER THE FIRST ADJUSTMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24916692 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED FROM THE LEFT EYE PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO A DECREASE IN VISION AND VISUAL DISTURBANCE.

  Patient problems: Visual Disturbances

  MAUDE report 24794850 ↗
• InjuryMar 31, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT COMPLETED TWO LIGHT ADJUSTMENTS ON (B)(6) 2024 AND DID NOT RETURN FOR LOCK-IN LIGHT TREATMENTS. APPROXIMATELY 30 MONTHS AFTER IMPLANTATION, THE PATIENT RETURNED TO CLINIC COMPLAINING OF BLURRY VISION. ON (B)(6) 2026 THE PHYSICIAN NOTED IOL SURFACE CHANGES CONSISTENT WITH POLYMERIZATION. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL+ (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24743632 ↗
• InjuryMar 6, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2023. DURING THE POSTOPERATIVE PERIOD, PATIENT HAD 4 LIGHT ADJUSTMENTS THAT BROUGHT THEIR DISTANCE VISION TO PLANO SPHERE AS PLANNED, BUT NO LOCK-IN TREATMENTS WERE COMPLETED DUE TO THE PATIENT'S DESIRE FOR BETTER NEAR VISION. UPON RETURNING TO THE CLINIC ON (B)(6) 2024, THE PATIENT COMPLAINED OF BLURRY DISTANCE VISION AND GLARE AND A 5TH ADJUSTMENT WAS PERFORMED. NO LOCK IN TREATMENTS WERE PERFORMED BEFORE THE LAL WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24538186 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PIGMENT ON THE LENS, NOTED POSTOPERATIVELY. THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24216107 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24080813 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 23074598 ↗
• InjuryAug 14, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +22.0D) WAS EXPLANTED DUE TO BLURRY VISION. LOCK-IN LIGHT TREATMENTS WERE PERFORMED WITHOUT ANY LIGHT ADJUSTMENS BEING PERFORMED.

  Patient problems: Blurred Vision

  MAUDE report 22806459 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND A NEW LAL (SN (B)(6), +23.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22293312 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22039198 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 22D) DURING PRIMARY CATARACT SURGERY, THE CAPSULAR BAG WAS TORN.  THE LAL WAS REPOSITIONED IN THE SULCUS WITH OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20783162 ↗
• InjuryNov 18, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED THAT DURING PRIMARY CATARACT SURGERY WHEN LOADING THE LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), 22D), THE SCRUB TECHNICIAN DAMAGED THE OPTIC BODY. AFTER THE LAL WAS DELIVERED INTO THE PATIENT'S EYE, THE SURGEON NOTICED A VISIBLE SCRATCH ON THE OPTIC BODY AND DECIDED TO EXCHANGE THE LAL. THE SURGEON NOTICED A SMALL ANTERIOR CAPSULE TEAR AFTER THE LAL WAS EXCHANGED. AN IOL FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT DUE TO THE SITE NOT HAVING ANOTHER LAL AVAILABLE FOR IMPLANTATION.

  Patient problems: Capsular Bag Tear

  MAUDE report 20708428 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20251229 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO BLURRY VISION AND DIPLOPIA. AN LAL (SN (B)(6), +22.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 08/14/2024.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 20212938 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT WHILE ATTEMPTING TO IMPLANT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) IN A PATIENT WITH A HISTORY OF A TRAUMATIC CATARACT, THE LAL FELL INTO THE VITREOUS AS A RESULT OF WEAKENED/BROKEN ZONULES. THE PHYSICIAN STOPPED THE SURGERY. THE PATIENT UNDERWENT A SECONDARY PROCEDURE THAT EVENING WHERE THE LAL WAS REMOVED FROM THE EYE AND AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THE PHYSICIAN NOTED THAT THE PRIOR OCULAR TRAUMA, WHICH FORMED THE CATARACT, WEAKENED THE ZONULES TO THE POINT THAT THEY WERE UNABLE TO HOLD THE LENS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/31/2024.

  Patient problems: Zonular Dehiscence

  MAUDE report 20082255 ↗
• InjuryMay 17, 2024Optical Decentration; Optical Decentration

  A PHYSICIAN REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS TILTED IN THE PATIENT'S EYE AFTER THE PRIMARY CATARACT SURGERY ON (B)(6), 2024. A SECONDARY SURGERY WAS CONDUCTED ON (B)(6), 2024, TO REPOSITION THE LENS; HOWEVER, THE LENS WAS NOT ABLE TO BE REPOSITIONED DUE TO FIBROSIS. THE LENS WAS LEFT IN THE EYE AS IS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 04/25/2024.

  Patient problems: Fibrosis

  MAUDE report 19347347 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19289269 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT DURING THE IMPLANT SURGERY ON (B)(6) 2023 FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D), A CAPSULAR BAG TEAR OCCURRED. THE SURGEON EXPLANTED THE ORIGINAL LAL AND PERFORMED A VITRECTOMY. THEN IMPLANTED A NEW LAL IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 17330271 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4). +22.0D) WAS EXPLANTED DUE TO THE PATIENT WAS UNABLE TO TOLERATE HYPEROPIA AND ASTIGMATISM. THE LENS WAS EXPLANTED AND ANOTHER LAL (SN (B)(4). , +22.5D) WAS IMPLANTED ON (B)(6) 2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 16616113 ↗