MAUDE Adverse Event Report: RxSight, Inc. Light Adjustable Lens+ (LAL+)

Model Number	60007
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens+ (lal+) was explanted from the left eye (os) due to blurred vision and changes in manifest refraction (mr) secondary to suspected photopolymerization.The patient had completed two light treatments an no lock-in treatments before presenting to clinic one year later, complaining of blurry vision os.Slit lamp examination revealed a small central bulge on the lal+.Additionally, the patient reported not wearing rxsight uv protective eyewear while swimming.The lal+ was explanted and replaced with another lal+ without complications.
Additional Manufacturer Narrative
Per the instructions for use (ifu), use of the lal is contraindicated in cases where: "the patient is unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of uv protective eyewear." additionally, "seventeen (17) to 24 days after surgery, the patient is to return for examination and a 1st adjustment treatment.Subsequent second and third adjustment treatments, if necessary, are all separated by 3-7 days.The patient will receive the 1st lock-in treatment 3-7 days after the final adjustment treatment.If necessary, lock-in #2 may be performed 3-7 days after lock-in #1." manufacturing records were reviewed and found no deviations, non-conformance, or other manufacturing issues related to the reported event.The product was received by the manufacturer and is pending investigation.Manufacturer reference#: (b)(4).

• 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 ; +1(949)273-6163
• MDR Report Key: 50915980
• Report Number: 3012712027-2026-00422
• Device Sequence Number: 5330488
• Product Code: PZK
• UDI-Device Identifier: 00818806021590
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/28/2026

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: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-006984
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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 Sex: Male