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

Model Number	60005
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.The explanted lal was returned to rxsight.A visual inspection of the lal confirmed the reported distortion, indicative of polymerization.Per the instructions for use (ifu), contraindications include patients ".Unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of uv protective eyewear.".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" manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that a patient was implanted with the light adjustable lens (lal).Postoperatively, the patient completed 4 light adjustments and no lock-in treatments.The patient presented at the clinic approximately 13 months after initial implantation with a visual acuity of 20/30 and high astigmatic error with distortion on retinoscopy exam.The site reported that the patient was exposed to arc light when welding and a slit lamp exam performed by the site found an area of distortion that is consistent with polymerization.Approximately 13 months after implantation, the lal was explanted.

• 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
• MDR Report Key: 25681653
• Report Number: 3012712027-2026-00321
• Device Sequence Number: 20001138
• Product Code: PZK
• UDI-Device Identifier: 00818806020777
• UDI-Public: (01)00818806020777(11)240914(17)270831
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-007379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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: 49 YR
• Patient Sex: Male