MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)

Model Number	60005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient was implanted with the light adjustable lens (lal, sn (b)(6), +25.0d) on (b)(6) 2024.The patient did not complete required lock-in light treatments.Approximately 12 months after implantation, the patient presented complaining of blurry distance vision in both eyes and reported that they used a tanning bed 20 times.The lal was explanted on (b)(6) 2025.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional information.Updates to section h6.Based on the reported event details, the patient did not complete required lock-in treatments and was exposed to uv light via multiple uses of a tanning bed.Therefore, the most likely cause of the patient's reported bilateral blurry vision is their exposure to uv light prior to completing lock-in treatments.Per the ifu, contraindications include patients ".Unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of uv protective eyewear.".Additionally, the ifu provides the following precaution: ".The implanted lal must undergo a minimum of two treatments (one adjustment plus a lock-in light treatment) with the light delivery device beginning at least 17-21 days post-implantation.".The ifu also provides potential risks of the lal, including: ".If the eye is exposed to bright lighting without the use of uv protective eyewear before 24 hours after the final lock-in treatment, the lal can change unpredictably, causing aberrated optics and blurred vision which might necessitate explantation of the lal.".

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163-159
• MDR Report Key: 21891128
• Report Number: 3012712027-2025-00095
• Device Sequence Number: 20929491
• Product Code: PZK
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004745
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male