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	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a light adjustable lens (lal sn (b)(6) +18.5d) was explanted due to a refractive surprise after implantation and one light treatment visit.The lal was explanted and replaced with another lal of a different power (sn (b)(6), +26.0d).Rxsight's date of first awareness was 08/31/2023.
Additional Manufacturer Narrative
The site reported that the patient had a previous superficial keratectomy (sk) with a different clinic and doctor that left too much irregularity on his cornea.After the initial light adjustable lens implant (lal sn (b)(6), +18.5d), there was a large refractive surprise.The treating physician realized that the patient needed to have a topography-guided lasik to try and fix the irregularity prior to any light treatment being performed.After the lasik was completed, the patient needed a photorefractive keratectomy (prk) to correct for the irregularity centrally on the cornea.At this point, a light treatment was completed for the eye.The patient ended up with a manifest refraction of +4.50 +1.50 x 123.The treating physician determined that the refraction was too high to be adjusted and opted to explant the lal and replace it with another lal of a different power (sn (b)(6), +26.0d).The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.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: 17848875
• Report Number: 3012712027-2023-00083
• Device Sequence Number: 4387233
• Product Code: PZK
• UDI-Device Identifier: 00818806020647
• UDI-Public: 01008188060206471122101117250930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 09/30/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White