Light Adjustable Lens (LAL) 60007-0185Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00818806021552), received between Jul 9, 2024 and Aug 14, 2026 — classified as 21 injuries.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Visual Disturbances

  MAUDE report 50262375 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens+ was explanted from the right eye due to dissatisfaction with the refractive target and the patient's complaint of halos and "smudgy" visual acuity. A Light Adjustable Lens was implanted as a replacement. No additional information was provided.

  Patient problems: Visual Disturbances

  MAUDE report 50130584 ↗
• InjuryJul 1, 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 THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LAL+ IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25681654 ↗
• 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 APPROXIMATELY 7 MONTHS AFTER COMPLETION OF LIGHT TREATMENTS DUE TO MONOCULAR DIPLOPIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Diplopia/Double Vision

  MAUDE report 25480545 ↗
• 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), +18.5D) WAS NOTED TO HAVE 2 CONCENTRIC RINGS UPON EXAMINATION. THE LAL WAS LATER EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24790376 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.5D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24771518 ↗
• InjuryMar 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), +18.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL (SN (B)(6), +19.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24576293 ↗
• 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)(4), +18.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378614 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRED VISION SECONDARY TO RESIDUAL REFRACTIVE ERROR.

  Patient problems: Blurred Vision

  MAUDE report 24235084 ↗
• InjuryDec 31, 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), +18.50D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 23936889 ↗
• InjuryDec 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), +18.5D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LAL+ (SN (B)(6), +18.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23829709 ↗
• InjuryNov 26, 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), +18.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET. A NEW LAL+ (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23658508 ↗
• InjuryOct 24, 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), +18.5D) WAS EXPLANTED DUE TO DIPLOPIA AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 23386490 ↗
• InjuryJul 9, 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), +18.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22460861 ↗
• InjuryJun 26, 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+,(B)(6), +18.5) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, (B)(6), +18.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22342660 ↗
• InjuryMay 14, 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), +18.5D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH DISTANCE VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22021608 ↗
• InjuryMay 7, 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), +18.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR VISION. A LAL (SN (B)(6), +17.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21981414 ↗
• InjuryMay 1, 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), +18.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR VISION. A NEW LAL (SN (B)(6), +18.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21947090 ↗
• InjuryFeb 6, 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), +18.5D) A CAPSULE TEAR OCCURRED. A VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED VIA OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21323276 ↗
• InjuryJan 7, 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 LASIK AND LIMBAL RELAXING INCISIONS HAD THEIR LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +18.5D) EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES, AND A NEW LAL+ (SN (B)(6), +18.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21095849 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT DEVELOPED ENDOPHTHALMITIS AFTER PRIMARY CATARACT SURGERY. A VITREOUS TAP PERFORMED TWO WEEKS POSTOP CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS EPIDERMIDIS. THE IMPLANTED LAL+ (LAL+, SN (B)(6), +18.5 D) WAS EXPLANTED ON (B)(6) 2024 AND CULTURED. THE RESULTING CULTURE OF THE EXPLANTED LAL+ WAS UNREMARKABLE. THE PATIENT WAS LEFT APHAKIC FOLLOWING THE EXPLANTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/13/2024.

  Patient problems: Endophthalmitis

  MAUDE report 19706024 ↗