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	Blurred Vision (2137)
Date of Event	05/15/2024
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 a patient's light adjustable lens (lal, sn (b)(6), +17.5d) was explanted from the left eye (os) and a new light adjustable lens+ (lal+, sn (b)(6), +18.0d) was implanted as a replacement due to difficulty neuro-adapting.Rxsight's first awareness of this event was on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information, regarding the patient's visual acuity and manifest refraction was obtained by rxsight.Sections b5 and b6 were updated.The returned device was evaluated and no device issues were found.Section h6 codes were updated.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported, to rxsight.That a patient's light adjustable lens (lal, sn#: (b)(6) +17.5d) was explanted from the left eye (os).And a new light adjustable lens+ (lal+, sn#: (b)(6) +18.0d) was implanted as a replacement, due to reduced uncorrected distance vision with -1.75 manifest refraction (mr).Following two light treatments on the new lal+.Uncorrected distance visual acuity (ucdva) was 20/40, with a mr of -0.75.

• 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: 19543998
• Report Number: 3012712027-2024-00095
• Device Sequence Number: 18029855
• Product Code: PZK
• UDI-Device Identifier: 00818806020623
• UDI-Public: 01008188060206231123111617261031
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-005478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/15/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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: 71 YR
• Patient Sex: Male