RxSight Light Adjustable Lens (RxLAL) 60005-3190Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00818806020654), received between Feb 9, 2022 and Sep 21, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Optical Problem” (3 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was explanted from the left eye due to patient dissatisfaction with visual acuity and dysphotopsia. Prior to lens explant, the patient completed all necessary light treatments targeting near vision for the left eye. A replacement Light Adjustable Lens (LAL) was implanted without complications.

  Patient problems: Visual Disturbances

  MAUDE report 50839854 ↗
• InjurySep 17, 2026Optical Decentration

  A site reported to RxSight that a patient presented to the clinic with complaints of shadowing. During postoperative examination, the Light Adjustable Lens (LAL) was observed to be decentered. It was subsequently noted that one haptic was positioned in the sulcus rather than within the capsular bag. A secondary surgical procedure was performed, during which the lens was successfully repositioned. No additional information has been provided.

  Patient problems: Visual Disturbances

  MAUDE report 50807904 ↗
• InjurySep 16, 2026Optical Problem

  A site reported to RxSight that after a patient's Light Adjustable Lens (LAL) was implanted, the patient underwent 3 light adjustments and 1 Lock-in treatment postoperatively. The patient returned to the clinic approximately 3 years after implantation and a slit lamp exam found evidence of a suspected central distortion that is consistent with photopolymerization. A fourth light adjustment and second Lock-in were then performed. The LAL was subsequently explanted and a vitrectomy was performed before a new LAL was implanted as a replacement.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50790249 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25681656 ↗
• InjuryApr 6, 2026Material Split, Cut or Torn

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) ON (B)(6) 2026, BUT THE LENS WAS NOTED TO HAVE A CHIP POSTOPERATIVELY. THE LAL WAS EXPLANTED THE SAME DAY AND A NEW LAL (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790378 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378601 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378540 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D). THE LENS WAS REMOVED FROM THE EYE DURING THE SAME SURGICAL PROCEDURE AND A VITRECTOMY WAS PERFORMED. A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24274199 ↗
• InjuryDec 22, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +19.0D) ON (B)(6) 2024. THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS AND DID NOT COMPLETE THE REQUIRED LOCK-IN TREATMENTS. ON (B)(6) 2025, APPROXIMATELY 15 MONTHS AFTER IMPLANTATION, THE TREATING PHYSICIAN NOTED A CENTRAL BUMP/SHAPE ALTERATION ON THE LAL THAT WAS CONSISTENT WITH POLYMERIZATION. THE LAL WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 23865330 ↗
• InjuryOct 29, 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), +19.0D) WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS DUE TO AN INCORRECTLY CHOSEN IOL POWER. A NEW LAL (SN (B)(6), +15.0D) WITH A DIFFERENT POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 23417397 ↗
• InjuryJul 15, 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, (B)(6), +19.0D) WAS EXPLANTED. A NEW LAL (SN (B)(6), +19.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22510092 ↗
• InjuryJun 3, 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), +19.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES PRIOR TO LIGHT TREATMENTS AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22137774 ↗
• InjuryJun 2, 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), +19.0D) WAS EXPLANTED DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT. A CAPSULAR BAG TEAR OCCURRED DURING THE LAL EXCHANGE AND THE NEW LENS WAS PLACED IN THE SULCUS WITH OPTIC CAPTURE.

  Patient problems: Blurred Vision; Capsular Bag Tear

  MAUDE report 22125272 ↗
• InjuryNov 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0 D) WAS SUCCESSFULLY IMPLANTED INTO THE CAPSULAR BAG OF A PATIENT. A CAPSULAR TENSION RING WAS UTILIZED DUE TO ZONULAR WEAKNESS. AS THE CAPSULAR BAG CONTRACTED WITHIN THE POSTOPERATIVE PERIOD, THE SURGEON NOTED THE SUPERIOR HAPTIC TO BE SEPARATING FROM THE SUPERIOR OPTIC JUNCTION AND EVENTUALLY COMPLETELY DETACHED. THE SURGEON DECIDED TO LEAVE THE LENS IN PLACE AS THE OPTIC REMAINED CENTERED. AFTER A SUBSEQUENT YAG PROCEDURE, THE LAL DISLOCATED AND NEEDED TO BE EXPLANTED. ANOTHER LAL (SN (B)(6), +19.0 D) WAS IMPLANTED INTO THE SULCUS AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20793194 ↗
• InjuryNov 26, 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 WITH A HISTORY OF IRREGULAR ASTIGMATISM HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 20789553 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) IN (B)(6) 2024. SIX MONTHS LATER, IT WAS DETERMINED VIA SLIT LAMP AND LIGHT DELIVERY DEVICE IMAGES THAT RETAINED CORTEX (FROM THE ORIGINAL CATARACT EXTRACTION) WAS STILL PRESENT IN THE EYE LEADING TO VISION FLUCTUATIONS AND A LONG-STANDING OCULAR INFLAMMATORY RESPONSE POSTOPERATIVELY. THE PATIENT WAS EVALUATED BY A RETINAL SPECIALIST IN (B)(6) 2024 AND UNDERWENT A VITRECTOMY. ON (B)(6) 2024, THE LAL WAS EXPLANTED, AND A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 20764693 ↗
• InjuryOct 15, 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), +19.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH DISTANCE AND NEAR VISION. A NEW LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.5D) WAS IMPLANTED AS REPLACEMENT AND 16 DAYS AFTER LENS EXCHANGE, THE PATIENT IS REPORTED TO BE HAPPIER WITH THEIR VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 09/17/2024. REFERENCE REPORT # 3012712027-2024-00178 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20456393 ↗
• InjuryAug 15, 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), +19.0D) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO PATIENT DISSATISFACTION AND A NEW LAL (SN (B)(6), +19.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/16/2024.

  Patient problems: Blurred Vision

  MAUDE report 19995856 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +19.0D) WAS IMPLANTED ON (B)(6) 2023, WITH ANOTHER LAL IMPLANTED IN THE FELLOW EYE SEPARATELY. NOT ALL REQUIRED LOCK-IN TREATMENTS WERE COMPLETED DURING THE POST-OPERATIVE PERIOD. ON (B)(6) 2024, APPROXIMATELY 16 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO DISSATISFACTION WITH VISION AND DIPLOPIA. AN INTRAOCULAR LENS (IOL) FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/10/2024.

  Patient problems: Diplopia/Double Vision

  MAUDE report 19955957 ↗
• InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (B)(6) WAS IMPLANTED BACKWARDS IN THE LEFT EYE (OS) DURING PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS COMPLETED TO EXPLANT THE LAL AND IMPLANT A NEW LAL IN THE PROPER ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2024. REFERENCE REPORT #(B)(4)FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19288933 ↗
• InjuryJan 30, 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, SN (B)(6), +19.0) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND ANOTHER LAL (SN (B)(6), +19.5D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 01/02/2024.

  Patient problems: Blurred Vision

  MAUDE report 18610850 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION. ANOTHER LAL WAS IMPLANTED AS REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 12/14/2023.

  Patient problems: Visual Impairment

  MAUDE report 18477147 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL SN: (B)(6), +19.0D) EXPLANTED FROM THE RIGHT EYE (OD) DUE TO RESIDUAL REFRACTIVE ERROR. THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL (SN: (B)(6), +18.5D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 11/21/2023. REFERENCE MDR 3012712027-2023-00116 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Disturbances

  MAUDE report 18380293 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL SN (B)(6)) EXPLANTED FROM THE LEFT EYE (OS) DUE TO RESIDUAL REFRACTIVE ERROR. THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL (SN (B)(6)). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(3) 2023. REFERENCE MDR 3012712027-2023-00115 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Disturbances

  MAUDE report 18375569 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT AFTER DELIVERY OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D), THE PHYSICIAN OBSERVED A POSTERIOR CAPSULE TEAR AND IMPLANTED THE LAL IN THE SULCUS. AN ANTERIOR VITRECTOMY WAS ALSO PERFORMED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 18242720 ↗