Light Adjustable Lens (LAL) 60007-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818806021668), received between Jun 18, 2024 and Aug 6, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Optical Decentration” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Optical Decentration

  A site reported to RxSight that a bilaterally implanted patient underwent explantation of the Light Adjustable Lens+ (LAL+) in the right eye after two adjustments due to a decrease in visual acuity. Following the first adjustment, the lens was observed to be slightly decentered. The patient was reported to be doing well post-explant. No additional information is available.

  Patient problems: Visual Impairment

  MAUDE report 50159646 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +24.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET. A NEW LAL (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24677927 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +24.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 24379292 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +24.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION. A NEW LAL (SN (B)(6),+21.5 D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23779729 ↗
• InjuryOct 24, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED THAT A CAPSULAR TEAR OCCURRED DURING IMPLANTATION OF A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +24.0D), CAUSING THE LENS TO FALL POSTERIORLY TO THE CAPSULAR BAG. THE SURGEON WAS UNABLE TO REMOVE THE LAL+ DURING PRIMARY SURGERY. ADDITIONALLY, THE TRAILING HAPTIC WAS DISINSERTED FROM ITS JUNCTION DURING THE LENS EXTRACTION ATTEMPT. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A RETINAL SPECIALIST, WHO PERFORMED THE LAL EXPLANT. A NEW LAL WAS IMPLANTED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23383290 ↗
• InjurySep 17, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +24.0D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2025. POSTOPERATIVELY, THE PATIENT UNDERWENT 1 LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS. ON (B)(6) 2025, THE LAL+ WAS EXPLANTED AND REPLACED WITH A NEW LAL+. THE SITE REPORTED THAT THE EXPLANTED LENS HAS A "WARPED" APPEARANCE CONSISTENT WITH POLYMERIZATION. THE PATIENT REPORTED TO THE TREATING PHYSICIAN THAT THEY DID NOT WEAR THE PROVIDED UV PROTECTIVE EYEWEAR WHILE "GARDENING."

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23073858 ↗
• InjuryAug 27, 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), +24.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22903336 ↗
• InjuryJul 25, 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), +24.0D) WAS EXPLANTED DUE TO DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +23.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22609572 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A POSTERIOR CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +24.0D). THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22609505 ↗
• InjuryJun 25, 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+, (B)(6), +24.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Disturbances

  MAUDE report 22330216 ↗
• InjuryJun 11, 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), +24.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION.

  Patient problems: Blurred Vision

  MAUDE report 22188685 ↗
• InjuryJun 6, 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), +24.0 D) WAS EXPLANTED DUE TO BLURRY DISTANCE VISION. A NEW LAL (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22160348 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A HISTORY OF PRIOR INTRAOCULAR LENS (IOL) EXCHANGE (MULTIFOCAL IOL TO LIGHT ADJUSTABLE LENS+) HAD THEIR LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6)) EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21305476 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +24.0D) DURING PRIMARY CATARACT SURGERY ON (B)(6) 2024, A CAPSULAR BAG TEAR WAS NOTED AFTER DELIVERY OF THE LAL+ INTO THE EYE; THE LAL+ WAS DELIVERED UPSIDE DOWN AND UPON ATTEMPTING TO FLIP THE LENS, THE TRAILING HAPTIC DISINSERTED. THE LENS WAS LEFT IMPLANTED. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED (B)(6) 2024 TO EXPLANT THE LAL+ AND IMPLANT AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19562946 ↗