MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); INTRAOCULAR LENS

Model Number	60005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician reported a patient undergoing femtosecond laser-assisted cataract surgery had a capsule tear during cataract surgery.The device history record for the lens was reviewed.No issues were noted.The lens remains implanted in the patient's eye.The surgical video of the lens implantation was provided.The video did not show when the tear had occurred, although it was noted that capsular tags were present and appeared to complicate the capsulotomy step of the cataract procedure, prior to crystalline lens removal and light adjustable lens insertion.
Event or Problem Description
Physician reported a patient undergoing femtosecond laser-assisted cataract surgery had a capsule tear during cataract surgery.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10685519
• Report Number: 3012712027-2020-00029
• Device Sequence Number: 436790
• Product Code: HQL
• UDI-Device Identifier: 00818806020258
• UDI-Public: 010081880602025817220630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other