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	10/12/2022
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.The initial lal implant was completed on (b)(6) 2022 with no complications.The initial lal with a lens power of 23.5d.At the postop day 1 visit, the patient's vision was: ucdva 20/200, mr +3.50 sph.At this time, the treating physician decided to have an explant in order to lower the refractive power.On (b)(6) 2022, the initial lal (power 23.5d) was explanted and another lal (power 26.0d, sn (b)(4) was implanted without complications.On (b)(6) 2022, during the postop day 1 visit after the second implant, the patient's vision was ucdva 20/50.The above information suggests that there were no issues with the initial lal that was explanted, instead, the initial lens power choice was not a good fit for this patient.Once the appropriate lens power was chosen, the patient's vision improved.The explanted lens (sn: (b)(4) is currently undergoing evaluation by rxsight.Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a light adjustable lens (lal) has been explanted prior to any light treatment due to the patient having a large refractive error of +3.50 sphere.The explanted lal had a power of 23.5d.While the second lal that was implanted had a power of 26.0d.Rxsight's first awareness of the event was on (b)(6) 2022.

• 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: 15777450
• Report Number: 3012712027-2022-00051
• Device Sequence Number: 17811416
• Product Code: PZK
• UDI-Device Identifier: 00818806020746
• UDI-Public: 01008188060207461122051017250430
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: 04/30/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2022
• 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: 70 YR
• Patient Sex: Female