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

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Codes	Visual Disturbances (2140); Capsular Bag Tear (2639)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that on (b)(6) 2023 during the implant procedure for a light adjustable lens (lal sn (b)(6), +16.0d), a capsular bag tear occurred.The surgeon noted the entire lens was in the bag but decentered nasally by about 2-3 mm.No vitreous loss was observed.At a post-operative follow-up visit on (b)(6) 2023, the patient's vision was reported to be 20/20 with manifest refraction being +0.50 +0.50 x180; however, the patient reports dysphotopsia and diplopia.On (b)(6) 2023, the surgeon performed a repositioning of the lal.Rxsight's first awareness of this event was on 04/27/2023.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The surgeon noted that the entire lens was in the bag and he was able to complete the surgery; however, the lens was decentered nasally about 2-3 mm.No vitreous loss was observed.The surgeon does not believe the cause of the capsular bag tear to be an issue with the integrity of the lal, haptic, handpiece, or cartridge.He noted the potential cause to be "tractional force".The lens remains implanted in the patient's eye.No further evaluation is possible at this time.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: 17014426
• Report Number: 3012712027-2023-00043
• Device Sequence Number: 12494748
• Product Code: PZK
• UDI-Device Identifier: 00818806020821
• UDI-Public: 01008188060208211123011117251231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/26/2023

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: 12/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004496
• 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: 04/27/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: Disability; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female