Light Adjustable Lens (LAL) 60007-0175Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00818806021538), received between Nov 6, 2024 and Apr 29, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Patient-Device Incompatibility

  A SITE REPORTED THAT A PATIENT PRESENTED DURING THE POSTOPERATIVE PERIOD FOLLOWING IMPLANTATION OF A LIGHT ADJUSTABLE LENS+ (LAL+) WITH A HYPEROPIC REFRACTIVE OUTCOME OF +7.50. TWO LIGHT TREATMENTS WERE ATTEMPTED TO CORRECT THE REFRACTIVE ERROR WITHOUT SUCCESS. THE PATIENT HAD A HISTORY OF PRIOR RADIAL KERATOTOMY (RK) PERFORMED YEARS BEFORE CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION (CEIOL). THE TREATING PHYSICIAN REPORTED THAT THE PRIOR RK INCISIONS WERE DEEPER THAN TYPICAL AND THAT KERATOMETRY VALUES WERE EXTREMELY FLAT, RANGING FROM APPROXIMATELY 20.00 TO 23.00 DIOPTERS. DUE TO THE DEGREE OF CORNEAL FLATNESS, THE ABERROMETER WAS NOT ABLE TO ACCURATELY CALCULATE THE INTRAOCULAR LENS POWER AND GENERATED AN INCORRECT RECOMMENDED LENS CALCULATION BASED ON A TARGET MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF PLANO. AN ATTEMPT WAS MADE TO EXPLANT THE LAL+ DUE TO THE REFRACTIVE OUTCOME; HOWEVER, EXPLANTATION WAS NOT SUCCESSFUL DUE TO AN UNKNOWN ISSUE WITH THE CAPSULAR BAG. THE TREATING PHYSICIAN PLANS TO IMPLANT A SECONDARY INTRAOCULAR LENS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25035328 ↗
• InjuryApr 29, 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 RIGHT EYE DUE TO BLURRY VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT. THE SITE REPORTED THAT POSTOPERATIVELY, THE PATIENT STATED THEIR EYE WAS "DOING WELL." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25033238 ↗
• InjuryNov 13, 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), +17.50D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT. A PARS PLANA VITRECTOMY WAS ALSO PERFORMED DURING THE SAME SURGERY.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23548904 ↗
• InjurySep 3, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL CHANGES AFTER USE OF A TANNING BED WITHOUT RXSIGHT UV PROTECTIVE SPECTACLES PRIOR TO ANY LIGHT TREATMENTS BEING PERFORMED. CLINICAL EXAMINATION REVEALED A CENTRAL AREA OF ELEVATION ON THE LENS.

  Patient problems: Blurred Vision

  MAUDE report 22953604 ↗
• InjuryAug 25, 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), +17.5D) WAS EXPLANTED FROM THEIR RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 22891325 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT UNDERWENT A PROCEDURE TO EXPLANT THE LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +17.5) FROM THE LEFT EYE DUE TO BLURRED VISION.

  Patient problems: Blurred Vision

  MAUDE report 22567016 ↗
• InjuryJun 26, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +17.5D) WAS REPOSITIONED. THE LENS WAS REPOSITIONED DUE TO THE LAL+ HAPTIC COMING OUT OF THE CAPSULAR BAG DUE TO SURGICAL REPAIR OF A RETINAL DETACHMENT (UNRELATED TO THE LAL+). NO LIGHT TREATMENTS OCCURRED PRIOR TO REPOSITIONING THE LENS.

  Patient problems: Blurred Vision

  MAUDE report 22342664 ↗
• InjuryApr 18, 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), +17.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21869405 ↗
• InjuryJan 10, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY, ON (B)(6) 2024, AFTER DELIVERY OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +17.5D) IN THE PATIENT'S EYE, IT WAS OBSERVED THAT A HAPTIC HAD DISINSERTED. AN ADDITIONAL PROCEDURE WAS COMPLETED ON (B)(6) 2024 TO EXPLANT THE LAL+ AND IMPLANT A NEW LAL+ (SN (B)(6), +17.5D) AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21128836 ↗
• InjuryNov 12, 2024Adverse 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), +17.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +17.5D) WAS IMPLANTED AS A REPLACEMENT. REFERENCE REPORT #3012712027-2024-00215 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20667043 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +17.5D). A VITRECTOMY WAS PERFORMED, AND THE LAL WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 20622882 ↗