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

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a patient's light adjustable lens (lal, sn (b)(6), +14.0d) was decentered.The treating physician believes the haptic may have been damaged when removing a iris ring from the eye during the primary surgery.After attempting to reposition the lens at the slit lamp, the surgeon determined it was necessary to perform repositioning in the or, which occurred on (b)(6) 2023.Rxsight's first awareness of this event was on (b)(6) 2023.
Additional Manufacturer Narrative
The site reported that a light adjustable lens (lal, sn (b)(6), +14.0d) was decentered.The patient complained of blurry vision, haziness, "ghost like vision", and light sensitivity.The treating physician believes he may have damaged one of the haptics during the original implant surgery.He noted that the patient has floppy iris syndrome and does not dilate well.He used an iris ring during the initial implant surgery and he thinks when removing the iris ring it might have bent the haptic.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
The site reported that a patient's light adjustable lens (lal, sn (b)(6)) was decentered.The treating physician believes the haptic may have been damaged when removing an iris ring from the eye during the primary surgery.After attempting to reposition the lens at the slit lamp, the surgeon determined it was necessary to perform an exchange of the lal in the or, which occurred on (b)(6) 2023.Another lal (+14.0d) was placed into the sulcus.A limited vitrectomy was also performed during the same surgery.
Additional Manufacturer Narrative
After submitting the initial report, rxsight received additional information clarifying that the secondary surgery was completed to explant and replace the existing lal.Event description in section b5 is being updated in this follow-up report.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: 18008003
• Report Number: 3012712027-2023-00091
• Device Sequence Number: 7478341
• Product Code: PZK
• UDI-Device Identifier: 00818806020586
• UDI-Public: 01008188060205861122062817250531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 05/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004068
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: 77 YR
• Patient Sex: Unknown