RxSight Light Adjustable Lens (RxLAL) 60005-3080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806020937), received between Feb 18, 2025 and May 28, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A HAPTIC TORE THE POSTERIOR CAPSULE DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS. THE LENS WAS PLACED IN THE SULCUS. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 25325833 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT RECEIVED A LIGHT ADJUSTABLE LENS (LAL) AS A REPLACEMENT TO THEIR EXPLANTED LIGHT ADJUSTABLE LENS+ (LAL+). AT ONE DAY POSTOP, THE PATIENT REPORTED RUBBING HER EYE, CAUSING THE MAIN INCISION TO LEAK. A BANDAGE CONTACT LENS WAS APPLIED. THE NEXT DAY, THE PATIENT PRESENTED WITH WAXY VISION, COLLAPSED ANTERIOR CHAMBER, AND DECOMPENSATED CORNEA. THE SURGEON SUCCESSFULLY PERFORMED SAME-DAY WOUND REVISION WITH SUTURES, AND VISION WAS IMPROVED THE FOLLOWING DAY.

  Patient problems: Corneal Decompensation; Visual Impairment; Wound Dehiscence

  MAUDE report 24879776 ↗
• InjuryApr 11, 2026Optical Decentration

  A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +8.0D) WAS IMPLANTED (B)(6) 2025 DURING PRIMARY CATARACT SURGERY IN THE LEFT EYE WITH SULCUS PLACEMENT. POSTOPERATIVELY, THE LAL WAS OBSERVED DECENTERED AND THE PATIENT COMPLAINED OF VISUAL DISTURBANCES. THE TREATING PHYSICIAN ATTRIBUTED THE DECENTRATION OF THE LENS TO THE "FACE DOWN" POSITION REQUIRED OF THE PATIENT DURING A PROCEDURE ON (B)(6) 2025 TO REPAIR A RETINAL DETACHMENT IN THE RIGHT EYE. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REPOSITION THE LENS AND PERFORM AN ANTERIOR VITRECTOMY. AT THE PATIENT'S POSTOPERATIVE EXAM, ON (B)(6) 2025, THE PATIENT REPORTED INVOLVEMENT IN A CAR ACCIDENT ON (B)(6) 2025 AND COMPLAINED OF GLARE/HALOS IN THE LEFT EYE. THE PATIENT CONTINUED TO COMPLAIN OF VISUAL DISTURBANCES IN THE LEFT EYE DURING THE POSTOPERATIVE PERIOD AND IT WAS DETERMINED THAT THE LENS WAS DECENTERED TEMPORALLY. ON (B)(6) 2025, AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE LENS IN THE EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24849156 ↗
• MalfunctionDec 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE SURGEON WAS ABLE TO SUCCESSFULLY FLIP THE LENS TO THE CORRECT ORIENTATION DURING THE PROCEDURE; HOWEVER, THE LENS WAS SCRATCHED DURING THE PROCESS. THE SURGEON ELECTED TO LEAVE THE LENS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936888 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PSEUDOPHAKIC PATIENT'S SUBLUXATED INTRAOCULAR LENS FROM ANOTHER MANUFACTURER WAS REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +8.0D) VIA SCLERAL FIXATION. THE PATIENT COMPLETED ALL LIGHT TREATMENTS TWO MONTHS LATER WITH AN UNCORRECTED DISTANCE VISUAL ACUITY OF 20/15. APPROXIMATELY 14 MONTHS LATER, THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO REPOSITION THE IMPLANTED LAL USING SUTURES. THIS INTRAOCULAR LENS REPOSITIONING RESULTED IN A CHANGE IN UNCORRECTED DISTANCE VISUAL ACUITY AND MANIFEST REFRACTION. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO EXPLANT THE LAL (SN (B)(6), +8.0D) AND IMPLANT A NEW LAL (SN (B)(6), +8.0D) AS A REPLACEMENT..

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21401847 ↗