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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following successful cataract surgery and implantation of the light adjustable lens ((b)(6) 2019 for the left eye; (b)(6) 2019 for the right eye) and completion of light treatments of the lenses for both eyes, the patient complained of visual disturbances in the left eye only.Patient was determined to have irregular astigmatism in the left eye.The lens was explanted on (b)(6) 2020 (manufacturer's first awareness date was (b)(6) 2020) and a new light adjustable lens was implanted.The explanted lens was discarded by the customer site.No lens is expected to be returned for evaluation.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Following successful cataract surgery and implantation of the light adjustable lens ((b)(6) 2019 for the left eye; (b)(6) 2019 for the right eye) and completion of light treatments of the lenses for both eyes, the patient complained of visual disturbances in the left eye only.Patient was determined to have irregular astigmatism in the left eye.The lens was explanted on (b)(6) 2020 (manufacturer's first awareness date was (b)(6) 2020) and a new light adjustable lens was implanted.
Event or Problem Description
Manufacturer's first awareness date was 2/21/2020.
Additional Manufacturer Narrative
Manufacturer's first awareness date was 2/21/2020.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 9835314
• Report Number: 3012712027-2020-00002
• Device Sequence Number: 16857849
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 010081880602022717220131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 01/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-000939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/13/2020
• 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: Required Intervention