Light Adjustable Lens (LAL) 60007-0165Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818806021514), received between May 23, 2024 and Nov 14, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 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), +16.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 AND THE LAL+ WAS SUCCESSFULLY FLIPPED TO THE CORRECT ORIENTATION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23556426 ↗
• InjuryOct 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 80062730319, +16.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23438400 ↗
• InjurySep 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'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +16.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 22974394 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT IMPLANTED WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6) EXPERIENCED A HYPEROPIC REFRACTIVE SURPRISE FOLLOWING A REFRACTIVE LENS EXCHANGE. TWO ADJUSTMENTS WERE PERFORMED BEFORE THE PATIENT UNDERWENT PHOTOREFRACTIVE KERATECTOMY (PRK) TO ATTEMPT TO FURTHER REDUCE THE REFRACTIVE ERROR. THE LENS WAS SUBSEQUENTLY EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22522490 ↗
• InjuryMay 16, 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), +16.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22040832 ↗
• InjuryAug 24, 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+, (B)(6), +16.5D) WAS EXPLANTED DUE TO THE OBSERVATION OF AN APPARENT SLIGHT ANNULAR OBSCURATION ON THE LENS AND A NEW INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 07/26/2024.

  Patient problems: Visual Impairment

  MAUDE report 20058171 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY A HAPTIC DISINSERTED FROM THE OPTIC BODY WHEN DELIVERING THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), 16.5D). THE DAMAGED LAL+ WAS REMOVED AND REPLACED WITH ANOTHER LAL+. POST-OPERATIVELY, A PEAKED PUPIL WAS NOTED DUE TO IRIS CAPTURE OF THE SECOND LAL+, NECESSITATING ITS REPOSITIONING IN A SECONDARY PROCEDURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 04/24/2024.

  Patient problems: Eye Injury

  MAUDE report 19387628 ↗