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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported that a patient with a medical history of lasik surgery for both eyes was implanted with light adjustable lenses (lal) in both eyes.Right eye was implanted (b)(6) 2022.Left eye was implanted 06/23/2022.The left eye underwent two adjustments and did not complete required light treatments.The left eye's last available refraction and visual acuity on (b)(6) 2022 was "-0.25 sphere 20/25 +2".Prior to completing the required light treatments, the patient complained of glare and demanded an iol exchange.Rxsight's first awareness date was (b)(6) 2022.On (b)(6) 2022, the iol exchange for the left eye was confirmed to have been completed on (b)(6) 2022.Refer to mfr report #: 3012712027-2022-00039 for information on the patient's right eye.
Additional Manufacturer Narrative
The explanted lens has not been returned to manufacturer and is currently unavailable for evaluation.

• 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
• MDR Report Key: 15442887
• Report Number: 3012712027-2022-00040
• Device Sequence Number: 14851602
• Product Code: PZK
• UDI-Device Identifier: 00818806020586
• UDI-Public: 010081880602058617250331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 03/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2022
• 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