RxSight Light Adjustable Lens (RxLAL) 60005-3165Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00818806020609), received between Oct 13, 2022 and Sep 23, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Detachment of Device or Device Component

  A site reported to RxSight that upon implantation of a Light Adjustable Lens (LAL), it was noted the leading haptic had become severed. While attempting to remove the LAL, both haptics detached from the optic, resulting in the surgeon using intraocular scissors to section the lens to facilitate removal. A posterior capsular tear occurred during lens removal, requiring a vitrectomy. A replacement LAL was subsequently implanted successfully in the sulcus. Although a dispersive OVD was used intraoperatively to protect the corneal endothelium, the surgeon reported at the two-week postoperative visit that significant corneal edema persisted and expressed concern that endothelial compromise had occurred, potentially requiring future endothelial transplantation.

  Patient problems: Capsular Bag Tear; Corneal Edema; Corneal Endothelial Cell Loss

  MAUDE report 50868490 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED DUE TO VISUAL DISTURBANCES. DURING THE SURGERY TO EXPLANT THE LENS, A CAPSULAR TEAR OCCURRED AND AN ANTERIOR VITRECTOMY WAS PERFORMED. POSTOPERATIVELY, THE PATIENT REPORTED THAT THEIR SYMPTOMS HAD IMPROVED BUT WERE NOT COMPLETELY RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; Visual Disturbances

  MAUDE report 25175051 ↗
• InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.5D) WAS IMPLANTED ON (B)(6) 2025. DURING A POSTOPERATIVE EXAM, THE PATIENT HAD AN UNEXPECTED REFRACTION, AND IT WAS DETERMINED THAT THE INCORRECT INTRAOCULAR LENS POWER WAS INADVERTENTLY IMPLANTED. THE LAL WAS EXPLANTED (B)(6) 2025 AND A NEW LAL (SN (B)(6), +19.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 22137776 ↗
• InjurySep 6, 2024Optical Decentration; Adverse Event Without Identified Device or Use Problem; Optical Decentration; 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), +16.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND A NEW LAL (SN (B)(6), +16.5D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/09/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20164088 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT THE TRAILING HAPTIC OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) +16.5D) WAS DAMAGED DURING DELIVERY, LEADING TO REMOVAL OF THE LAL. AFTER REMOVAL, THE EYE WAS INITIALLY LEFT APHAKIC DUE TO THE PRESENCE OF ANTERIOR CHAMBER BLOOD. A SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2024 AND A SECOND LAL WAS IMPLANTED IN THE SULCUS DUE TO ZONULAR DEHISCENCE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/13/2024.

  Patient problems: Eye Injury

  MAUDE report 19102099 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS COMPLETED TO EXPLANT THE LAL AND IMPLANT A NEW LAL (SN (B)(6), +19.0D) IN THE PROPER ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/06/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18852291 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING THE IMPLANT SURGERY ON (B)(6) 2023 FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.5D), A CAPSULAR BAG TEAR OCCURRED; THE LENS WAS RETAINED IN THE SULCUS WITHOUT CAPTURE. THE SURGEON PERFORMED A VITRECTOMY WITH NORMAL CLOSURE. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 11/28/2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 18372662 ↗
• InjuryNov 17, 2023Adverse 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)) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. THE LAL WAS REPLACED WITH AN INTRAOCULAR LENS OF A DIFFERENT BRAND WITH +17.5D IOL POWER. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18166297 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +16.5D) WAS EXPLANTED DUE TO PATIENT EXPERIENCING BINOCULAR DIPLOPIA. THE LAL WAS EXPLANTED AND REPLACED WITH ANOTHER LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Diplopia/Double Vision

  MAUDE report 17848881 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT AFTER THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), 16.5D) WAS DELIVERED INTO THE EYE, THE SURGEON NOTICED THAT THE LEADING HAPTIC WAS MISSING. THE LENS WAS REMOVED FROM THE EYE. THE SURGEON NOTICED THAT THE CAPSULAR BAG WAS TORN AFTER LENS REMOVAL. A REPLACEMENT LAL WAS SUCCESSFULLY DELIVERED INTO THE SULCUS AND THE INCISION WAS CLOSED WITH ONE SUTURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022.

  Patient problems: Capsular Bag Tear

  MAUDE report 16164937 ↗
• InjuryOct 13, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED FROM THE PATIENT DUE TO BEING TILTED AND DECENTERED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15601327 ↗