Light Adjustable Lens (LAL) 60007-0215Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818806021613), received between Jun 21, 2024 and Sep 30, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50948497 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens+ was explanted due to the patient's dissatisfaction with distance and intermediate vision after completion of light treatments and a new Light Adjustable Lens implanted as a replacement. No additional information is available.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50018961 ↗
• InjuryJun 12, 2026Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A LIGHT ADJUSTABLE LENS+ (LAL+) PRESENTED TO THE CLINIC SEEKING A SECOND OPINION DUE TO CONCERNS WITH BOTH DISTANCE AND NEAR VISION. UPON EVALUATION, THE LAL+ WAS FOUND TO BE DISLOCATED. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED, INCLUDING IRIS FIXATION OF THE LENS AND PUPILLOPLASTY TO ADDRESS IRIS ATROPHY. THE PATIENT RETURNED ONE MONTH POSTOPERATIVELY REPORTING NO IMPROVEMENT IN REFRACTIVE ERROR. A PHOTOREFRACTIVE KERATECTOMY (PRK) PROCEDURE WAS SUBSEQUENTLY PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25487278 ↗
• InjuryMay 6, 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 REDUCED VISUAL QUALITY THAT ARE LIKELY ATTRIBUTABLE TO A PRE-EXISTING DECENTERED LASIK ABLATION. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY.

  Patient problems: Visual Disturbances

  MAUDE report 25095050 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24587414 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Blurred Vision

  MAUDE report 24514698 ↗
• InjuryFeb 27, 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), +21.5D) WAS EXPLANTED FROM THE LEFT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24471282 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +21.5D) WAS IMPLANTED ON (B)(6) 2024. AT THEIR FINAL LIGHT TREATMENT ON (B)(6) 2024, THE PATIENT REPORTED BLURRED VISION AND VISUAL DISTURBANCES. THE LENS WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24397575 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378613 ↗
• InjuryFeb 11, 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), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 24314616 ↗
• InjuryJan 9, 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), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +24.0D) WITH A DIFFERENT IOL POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24021705 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED TO RXSIGHT THAT THEIR LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.50D) WAS EXPLANTED AFTER THEY STATED THEY COULD NOT SEE AFTER SURGERY. PATIENT WAS CONCERNED THEY HAD A RETINAL DETACHMENT. THE SURGEON WAS ABLE TO SUCCESSFULLY EXPLANT THE LENS. THE PATIENT REPORTED THEY STILL COULD NOT SEE AFTER THE EXPLANT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23548947 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING DELIVERY OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.5D) A CAPSULE TEAR OCCURRED. A VITRECTOMY WAS PERFORMED, AND THE LAL+ WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22565873 ↗
• InjuryMay 30, 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), +21.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION. A NEW LAL+ (SN (B)(6), +13.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22119948 ↗
• InjuryApr 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), +21.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21858104 ↗
• InjuryNov 22, 2024Adverse 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)(6), +21.5D) WAS EXPLANTED ON (B)(6) 2024 DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR DISTANCE VISION. AN IOL FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 20764462 ↗
• InjuryAug 21, 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) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION AND NEGATIVE DYSPHOTOPSIA; A NEW LAL (SN (B)(6) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/22/2024.

  Patient problems: Visual Disturbances

  MAUDE report 20023109 ↗
• InjuryJun 21, 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), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH VISION, AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024. REFERENCE REPORT # 3012712027-2024-00108 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Disturbances

  MAUDE report 19589036 ↗