Light Adjustable Lens (LAL) 60007-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00818806021644), received between Oct 16, 2024 and Sep 19, 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.

• InjurySep 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50831676 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens was explanted from the left eye due to blurry vision and difficulty adapting to blended vision after 3 light adjustments.

  Patient problems: Blurred Vision

  MAUDE report 50212625 ↗
• 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), +23.0D) WAS EXPLANTED FROM THE RIGHT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24471283 ↗
• InjuryFeb 12, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +23.0D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT HAD 1 LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS POST-OPERATIVELY. UPON RETURNING TO CLINIC ON (B)(6) 2025, THE PATIENT COMPLAINED OF BLURRY VISION. THE PATIENT HAD AN ADDITIONAL LIGHT TREATMENT ON (B)(6) 2025 AND RETURNED TO CLINIC ON (B)(6) 2025 COMPLAINING OF CONTINUED BLURRY VISION AND HALOS. THE LAL+ WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2025 AND REPLACED WITH ANOTHER LAL+ (SN (B)(6), +23.0D).

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24328593 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24274180 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL (SN (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24269968 ↗
• InjurySep 19, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23.0D) REQUIRED SURGICAL INTERVENTION PRIOR TO LIGHT TREATMENTS TO CORRECT OPTIC-IRIS CAPTURE. SURGICAL INTERVENTION WAS PRECEDED BY THE TREATMENT OF PRESUMED ENDOPHTHALMITIS AFTER PRIMARY IMPLANTATION. SUBSEQUENTLY, THE PUPIL WAS MISSHAPED AND PIGMENT/INFLAMMATORY RESIDUE WAS OBSERVED ON THE LENS IMPLANT. THE PATIENT EXPERIENCED MONOCULAR DIPLOPIA AND HAZE AFTER TWO LIGHT TREATMENTS AND THE LAL+ REMAINS IMPLANTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 23097186 ↗
• InjuryJun 10, 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), +23.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Disturbances

  MAUDE report 22178497 ↗
• InjuryJan 17, 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), +23.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH DISTANCE VISION AS A RESULT OF THE CHOSEN REFRACTIVE TARGET BY THE TREATING PHYSICIAN. A NEW LAL+ (SN (B)(6), +23.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21181009 ↗
• InjuryJan 10, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23D), IMPLANTED (B)(6) 2024, DISLOCATED POSTOPERATIVELY DUE TO WEAK ZONULES. THE LAL+ WAS EXPLANTED FROM THE EYE ON (B)(6) 2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21127965 ↗
• InjuryOct 16, 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), +23.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND MONOCULAR DIPLOPIA AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT. FOLLOWING IMPLANTATION OF THE NEW LAL, THE PATIENT REPORTS THAT THE MONOCULAR DIPLOPIA WAS RESOLVED.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 20465290 ↗