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

Model Number	60005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a bilaterally implanted light adjustable lens (lal) patient had their lenses explanted due to having large refractive errors.The manifest refraction (mr) for the right eye postoperatively was +3.00 -1.25 x035, and the mr for the left eye postoperatively was +3.25 -1.50 x090.The explanted lals were replaced with new lals.Rxsight's first awareness of the event was on 03/07/2023.The lal that was explanted from the right eye (od) has serial number sn (b)(4) (+14.0d).Refer to mfr report #: 3012712027-2023-00028 for information on the patient's left eye.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The initial lal ((b)(4)) had a lens power of 14.0d.After the implant and prior to the first light treatment, the mr for the right eye was +3.00 -1.25 x035, which was an outcome with unexpectedly large refractive error.The decision was made to explant the original lens and implant a different lal.The above information suggests that there were no issues with the original lal that was explanted, instead, the initial lens power choice was not a good fit for this patient.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 ; 9492736163
• MDR Report Key: 16696702
• Report Number: 3012712027-2023-00027
• Device Sequence Number: 3629121
• Product Code: PZK
• UDI-Device Identifier: 00818806020586
• UDI-Public: 01008188060205861122082917250731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 04/06/2023

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: 07/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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 Sex: Unknown