RxSight Light Adjustable Lens (RxLAL) 60005-3185Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00818806020647), received between Jan 4, 2023 and Jul 31, 2026 — classified as 27 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 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 right eye due to blurry vision. A new LAL was implanted as a replacement. The patient is reported to be doing well post-operatively. No additional information has been provided.

  Patient problems: Blurred Vision

  MAUDE report 50105321 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S CAPSULAR BAG WAS PUNCTURED BY THE HAPTIC OF THE LIGHT ADJUSTABLE LENS (LAL) DURING IMPLANTATION. THE LAL WAS REMOVED FROM THE EYE AND ANOTHER LAL SUCCESSFULLY IMPLANTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25480569 ↗
• InjuryApr 30, 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 RIGHT EYE DUE TO DIPLOPIA AND BEING UNABLE TO ADJUST TO MONOVISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY.

  Patient problems: Diplopia/Double Vision

  MAUDE report 25049020 ↗
• InjuryApr 29, 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 RIGHT EYE DUE TO BLURRY, DECREASED VISION.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 25032566 ↗
• InjuryApr 22, 2026Material Opacification; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL) IN THE LEFT EYE. DURING THE POSTOPERATIVE PERIOD, THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. APPROXIMATELY 30 MONTHS AFTER IMPLANTATION, THE PHYSICIAN NOTED A CENTRAL OPACIFICATION ON THE LAL DURING A SLIT LAMP EXAM THAT IS CONSISTENT WITH PHOTOPOLYMERIZATION, AND THE LAL WAS SUBSEQUENTLY EXPLANTED. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24955511 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24816956 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS EXPLANTED DUE TO BLURRY VISION AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 24747878 ↗
• MalfunctionMar 18, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626405 ↗
• MalfunctionFeb 25, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6),+18.5D) WAS IMPLANTED BACKWARDS DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL ((B)(6), +18.5D) DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442893 ↗
• InjuryFeb 11, 2026Adverse 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), +18.5D) AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24314625 ↗
• InjuryNov 7, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) ON (B)(6) 2024. FOLLOWING THE FIRST LIGHT TREATMENT, THE PATIENT REPORTED GHOSTING IN THEIR VISION AND WAS TREATED FOR MULTIPLE EPISODES OF CYSTOID MACULAR EDEMA. THE LENS WAS OBSERVED TO BE SLIGHTLY TILTED, AND A SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REPOSITION THE LAL WITH REVERSE OPTIC CAPTURE. THE PATIENT'S SYMPTOMS CONTINUED AFTER THE REPOSITIONING AND A THIRD ADJUSTMENT LIGHT TREATMENT.

  Patient problems: Visual Disturbances

  MAUDE report 23500414 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A POSTERIOR CAPSULAR BAG TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D). THE LAL WAS REPOSITIONED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22330217 ↗
• 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 LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION. A NEW LAL (SN (B)(6), +18.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22135367 ↗
• InjuryMay 14, 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), +18.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL (SN: (B)(6), +18.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22019614 ↗
• InjuryFeb 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 WITH A HISTORY OF PRIOR INTRAOCULAR LENS (IOL) EXCHANGE (MULTIFOCAL IOL TO LAL) HAD THEIR LAL (SN (B)(6), +18.5 D) EXPLANTED FROM THE LEFT EYE ON (B)(6) 2025 DUE TO UNHAPPINESS WITH FINAL VISUAL OUTCOME.

  Patient problems: Visual Impairment

  MAUDE report 21305414 ↗
• InjuryDec 13, 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), +18.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH REFRACTIVE TARGET CHOSEN AND FINAL VISION.

  Patient problems: Blurred Vision

  MAUDE report 20926885 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) IN THE LEFT EYE ON (B)(6) 2023. MULTIPLE REFRACTIVE LIGHT TREATMENTS AND PRK ENHANCEMENT WERE PERFORMED, HOWEVER, NO LOCK IN TREATMENTS WERE COMPLETED. THE LENS WAS EXPLANTED FROM THE LEFT EYE ON (B)(6) 2024 DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 20859122 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) ON (B)(6)2023. THE PATIENT SUCCESSFULLY COMPLETED ALL LIGHT TREATMENTS; HOWEVER, THE PATIENT HAD DIFFICULTY ADJUSTING TO THE CHOSEN REFRACTIVE TARGET. AN ACRYLIC PIGGYBACK IOL WAS SUBSEQUENTLY IMPLANTED, BUT IT RESULTED IN THE PATIENT HAVING COMPLAINTS OF VISUAL DISTURBANCES. ON (B)(6)2024, THE PIGGYBACK IOL AND THE LAL WAS REMOVED FROM THE PATIENT'S EYE AND ANOTHER LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem; Visual Impairment

  MAUDE report 20559778 ↗
• 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 PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) ON (B)(6)2024. THE PRIMARY CATARACT SURGERY WAS CHARACTERIZED BY THE SITE AS ROUTINE AND UNREMARKABLE. ON (B)(6)2024, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS. A VITREOUS TAP WAS PERFORMED, AND THE CULTURE RETURNED NEGATIVE. THE LAL WAS EXPLANTED ON (B)(6)2024. ON (B)(6)2024, IT WAS REPORTED THAT THE ENDOPHTHALMITIS WAS MOSTLY RESOLVED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 09/16/2024.

  Patient problems: Endophthalmitis

  MAUDE report 20456505 ↗
• InjuryMay 17, 2024Adverse 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), +18.5D) DURING PRIMARY CATARACT SURGERY ON (B)(6) 2024, A POSTERIOR CAPSULE TEAR WAS NOTED, AND THE LENS DISLOCATED INTO THE POSTERIOR CHAMBER. AN ANTERIOR VITRECTOMY WAS PERFORMED. A SECONDARY PROCEDURE WAS PERFORMED 04/26/2024 TO COMPLETE A VITRECTOMY AND SCLERAL FIXATION OF THE LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19347063 ↗
• InjuryApr 23, 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), +18.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND ANOTHER LAL (SN (B)(6), +18.5D) IMPLANTED AS A REPLACEMENT. IN ADDITION, A PARS PLANA VITRECTOMY WAS PERFORMED ON THE EYE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/25/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19167957 ↗
• InjuryJan 10, 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) +18.5D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND REPLACED WITH A NEW LAL (SN (B)(6), +18.5D). THERE WERE NO REPORTED PATIENT COMPLICATIONS OR OTHER PROBLEMS FOLLOWING THE PROCEDURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 12/14/2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18484253 ↗
• 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 DELIVERY OF A LIGHT ADJUSTABLE LENS (LAL, SN(B)(6), +18.5D), THE CAPSULAR BAG WAS PUNCTURED. THE PARTIALLY DEPLOYED LAL WAS WITHDRAWN. ANOTHER LAL OF THE SAME POWER WAS IMPLANTED IN THE CAPSULAR BAG WITH NO COMPLICATIONS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 12/06/2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 18375454 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS EXPLANTED AND ANOTHER LAL (SN 70046110311, +18.5D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18051706 ↗
• InjurySep 29, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6) +18.5D) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE AFTER IMPLANTATION AND ONE LIGHT TREATMENT VISIT. THE LAL WAS EXPLANTED AND REPLACED WITH ANOTHER LAL OF A DIFFERENT POWER (SN (B)(6), +26.0D). RXSIGHT'S DATE OF FIRST AWARENESS WAS 08/31/2023.

  Patient problems: Visual Impairment

  MAUDE report 17848875 ↗