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

Model Number	60005
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported during delivery of the lal, the lens exited the cartridge abruptly, causing the haptic to tear the posterior capsular bag.The physician completed a vitrectomy, removed the lal, and implanted a li60 in the sulcus.Rxsight's first awareness of this issue was (b)(6) 2021.The device history record for the lens was reviewed.No issues were noted.The explanted lens has been returned and is currently being evaluated.
Event or Problem Description
The site reported during delivery of the lal, the lens exited the cartridge abruptly, causing the haptic to tear the posterior capsular bag.The physician completed a vitrectomy, removed the lal, and implanted a li60 in the sulcus.Rxsight's first awareness of this issue was (b)(6) 2021.
Event or Problem Description
The site reported during delivery of the lal, the lens exited the cartridge abruptly, causing the haptic to tear the posterior capsular bag.The physician completed a vitrectomy, removed the lal, and implanted a li60 in the sulcus.Rxsight's first awareness of this issue was 9/20/2021.
Additional Manufacturer Narrative
The site reported during delivery of the lal, the lens exited the cartridge abruptly, causing the haptic to tear the posterior capsular bag.The physician completed a vitrectomy, removed the lal, and implanted a li60 in the sulcus.Rxsight's first awareness of this issue was 9/20/2021.The explanted lens was returned for evaluation.Visual inspection found no issues with the returned lens.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: kelli carrillo ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 12656928
• Report Number: 3012712027-2021-00062
• Device Sequence Number: 4298808
• Product Code: PZK
• UDI-Device Identifier: 00818806020579
• UDI-Public: 01008188060205791121071317240630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 06/30/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: Other
• Patient Sex: Male