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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
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.A 61-year-old male patient underwent uncomplicated, cataract surgery with well-positioned, in-capsule implantation of a +23.0 diopter lal (sn: (b)(4) in the right eye on (b)(6) 2021.Examination on postoperative day 1 (pod1) showed findings consistent with tass (toxic anterior segment syndrome), which was also reported in 3 other eyes operated the same day using iols from different manufacturers.The tass outbreak was potentially linked to a pharmaceutical lot common to all cases.Despite aggressive management of tass, the eye required descemet stripping automated endothelial keratoplasty (dsaek) two months after surgery.The patient admitted to non-compliance with uv protection following dsaek procedure leading to a central zone of polymerization from ambient light exposure.The lal was explanted and exchanged with a different iol six months after surgery.The explanted lal was not returned to rxsight, but was analyzed by the university of utah ophthalmic pathology group, which noted a paracentral elevation on the lal.Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a light adjustable lens (lal) was explanted due to patient non-compliance with uv protection which led to an ambient zone formation.Rxsight's first awareness of this 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: 15857560
• Report Number: 3012712027-2022-00059
• Device Sequence Number: 17749779
• Product Code: PZK
• UDI-Device Identifier: 00818806020234
• UDI-Public: 01008188060202341120012817221231
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/23/2022

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: 12/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001536
• 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: 10/24/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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: 61 YR
• Patient Sex: Male