RxSight Light Adjustable Lens (RxLAL) 60005-3070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020920), received between Aug 8, 2024 and Feb 6, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Optical Decentration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 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)) WAS EXPLANTED DUE TO VISUAL DISTURBANCES WHICH MANIFESTED 3 MONTHS AFTER THE FINAL LOCK-IN AND A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21326731 ↗
• InjuryNov 1, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +7.0 D) WAS IMPLANTED (B)(6)2024 IN EXCHANGE FOR ANOTHER MANUFACTURER'S IOL. DURING THE POSTOPERATIVE PERIOD, THE PATIENT COMPLAINED OF DIPLOPIA AND THE DOCTOR OBSERVED THE IMPLANTED LAL TO BE DISLOCATED; THE PHYSICIAN CHOSE TO EXPLANT THE LAL ON (B)(6)2024 AND REPLACE WITH A NEW LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +7.0D).

  Patient problems: Diplopia/Double Vision

  MAUDE report 20592649 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +7.0D) IMPLANTED IN THE LEFT EYE ON (B)(6) 2022. ON (B)(6) 2024, 19 MONTHS AFTER THE ORIGINAL IMPLANTATION, THE LAL WAS EXPLANTED DUE TO THE DEVELOPMENT OF CELLULAR DEPOSITS THAT AFFECTED THE PATIENT'S VISION. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 07/09/2024. REFERENCE REPORT #3012712027-2024-00072 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19946113 ↗