RxSight Light Adjustable Lens (RxLAL) 60005-2215Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818806020203), received between Jul 22, 2020 and Jun 10, 2022 — classified as 13 injuries.

The most frequently reported specific device problem is “Optical Problem” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Optical Problem; Optical Problem

  SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 14654233 ↗
• InjuryJan 19, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 12/29/2021.

  Patient problems: Visual Impairment

  MAUDE report 13290423 ↗
• InjuryDec 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SITE REPORTED A LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE LENS WAS NOTED TO BE DISLOCATED, PREVENTING DESIRED REFRACTION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 13052824 ↗
• InjuryDec 20, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AS THE PATIENT DID NOT RETURN FOR ANY LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 13043183 ↗
• InjuryNov 23, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12861044 ↗
• InjuryNov 4, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THEIR VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12754636 ↗
• InjuryOct 27, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AS THE PATIENT DID NOT RETURN FOR LIGHT TREATMENTS FOLLOWING CATARACT SURGERY, AND THE LENS WAS NOT FUNCTIONING PROPERLY. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 10/1/2021.

  Patient problems: Visual Impairment

  MAUDE report 12704681 ↗
• InjurySep 2, 2021Optical Distortion; Optical Distortion

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO DISSATISFACTION WITH GLARE. THE PATIENT'S CORRECTABLE VISION WAS NOTED TO BE 20/15. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE. RXSIGHT'S FIRST AWARENESS OF THE ISSUE WAS (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 12416165 ↗
• InjuryJul 13, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 6/18/2021.

  Patient problems: Visual Impairment

  MAUDE report 12163976 ↗
• InjuryJun 11, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 11984472 ↗
• InjuryJan 26, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS.

  Patient problems: Visual Impairment

  MAUDE report 11233794 ↗
• InjurySep 24, 2020Misfocusing; Misfocusing

  DOCTOR ENTERED THE INCORRECT TARGET FOR THE LIGHT DELIVERY DEVICE. THE LIGHT DELIVERY DEVICE ADJUSTED THE LENS TO THE TARGET AS SPECIFIED BY THE DOCTOR, RESULTING IN UNDESIRED REFRACTIVE OUTCOME FOR THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 10581915 ↗
• InjuryJul 22, 2020Optical Distortion; Optical Distortion

  PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS IN THE LEFT EYE ON (B)(6) 2020. ADJUSTMENTS COMPLETED WITHOUT ISSUE. DUE TO COVID-19 IMPACT ON THE PROVIDER, THE PATIENT WAS UNABLE TO RETURN FOR LOCK-IN UNTIL (B)(6) 2020. WHEN IN CLINIC PRIOR TO LOCK-IN, PATIENT REPORTED VISUAL DISTURBANCES AND NON-COMPLIANCE WITH UV PROTECTIVE WEAR. THE LENS WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT'S FIRST AWARENESS OF THE EXPLANT WAS (B)(6) 2020).

  Patient problems: Visual Disturbances

  MAUDE report 10308212 ↗