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

Model Number	60007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that during primary cataract surgery, on (b)(6) 2024, a light adjustable lens+ (lal+, sn (b)(6), +16.0d) was implanted in the patient's eye in error instead of the originally intended lal+ (+9.0d), resulting in a +6.0d refractive surprise post cataract surgery.On (b)(6) 2024, the lal+ (sn (b)(6), +16.0d) was explanted and a new lal+ (+8.0d) implanted as a replacement.Rxsight's first awareness of this event was on 05/22/2024.

• 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: 19563155
• Report Number: 3012712027-2024-00099
• Device Sequence Number: 7704555
• Product Code: PZK
• UDI-Device Identifier: 00818806021507
• UDI-Public: 01008188060215071124012317261231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Model Number: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-005809
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic