Light Adjustable Lens (LAL) 60007-0170Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00818806021521), received between Jun 27, 2024 and Aug 11, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryAug 11, 2026Insufficient Device Problem Information

  A site reported to RxSight that a patient's Light Adjustable Lens+ (LAL+) was explanted and a vitrectomy was performed. No additional information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50210962 ↗
• InjuryJul 27, 2026Insufficient Device Problem Information

  A site reported to RxSight that a patient's Light Adjustable Lens+ was explanted due to being implanted backwards during the initial implantation surgery. A new LAL+ was implanted successfully as a replacement with no complications.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50010775 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ WAS EXPLANTED PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO MONOCULAR DIPLOPIA AND A NEW LIGHT ADJUSTABLE LENS IMPLANTED AS A REPLACEMENT. FOLLOWING THE LENS EXCHANGE SURGERY, THE PATIENT REPORTED THAT HE "CAN SEE NOW, JUST BLURRY." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Diplopia/Double Vision

  MAUDE report 25325835 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +17.0D). A VITRECTOMY WAS PERFORMED AND THE LAL+ WAS SUCCESSFULLY IMPLANTED IN THE SULCUS WITH REVERSE OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23706521 ↗
• InjuryOct 23, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +17.0) ON (B)(6) 2023. POSTOPERATIVELY, THE PATIENT DID NOT COMPLETE THE REQUIRED LOCK-IN TREATMENTS. ON (B)(6) 2025, THE PATIENT INFORMED THE SITE THAT THE LAL+ WAS PREVIOUSLY EXPLANTED AT A DIFFERENT SURGERY CENTER DUE TO DISSATISFACTION WITH VISION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23375253 ↗
• InjuryJul 25, 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), +17.0D) WAS EXPLANTED FROM THE LEFT EYE AND REPLACED WITH A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) DUE TO RESIDUAL REFRACTIVE ERROR AND BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22609571 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +17.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR NEAR VISION AS A RESULT OF THE CHOSEN REFRACTIVE TARGET; A NEW LAL+ (SN (B)(6), +18.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21180851 ↗
• InjuryNov 27, 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), +17.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +17.5D) WAS IMPLANTED AS A REPLACEMENT. REFERENCE REPORT #3012712027-2024-00208 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20792348 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT BILATERALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+) UNDERWENT A PROCEDURE TO EXPLANT THE LAL+ (SN (B)(6), +17.0) FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET; AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 20665461 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT UPON DELIVERY OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +17.0D), DURING PRIMARY CATARACT SURGERY, THE CAPSULAR BAG WAS TORN. A VITRECTOMY WAS PERFORMED AND THE LAL WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/25/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 20022580 ↗
• InjuryJun 27, 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), +17.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION AND A NEW LAL+ (SN (B)(6), +17.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/29/2024. REFERENCE REPORT #3012712027-2024-00104 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19630670 ↗