MAUDE Adverse Event Report: RXSIGHT RXSIGHT LIGHT ADJUSTABLE LENS; INTRAOCULAR LENS

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was implanted with the light adjustable lens in the left eye on (b)(6) 2020.Adjustments completed without issue.Due to covid-19 impact on the provider, the patient was unable to return for lock-in until (b)(6) 2020.When in clinic prior to lock-in, patient reported visual disturbances and non-compliance with uv protective wear.The lens was explanted on (b)(6) 2020 (rxsight's first awareness of the explant was (b)(6) 2020).Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned for evaluation and received on july 14, 2020.The lens had been cut into three pieces, with one of the cuts through the center of the lens optic.The lens had been cut in order to explant.Visual inspection of the lens fragments did not note of any unusual zones.An optical path difference of the lens also could not confirm any zone formation on the lens.
Event or Problem Description
Patient was implanted with the light adjustable lens in the left eye on (b)(6) 2020.Adjustments completed without issue.Due to covid-19 impact on the provider, the patient was unable to return for lock-in until (b)(6) 2020.When in clinic prior to lock-in, patient reported visual disturbances and non-compliance with uv protective wear.The lens was explanted on (b)(6) 2020 (rxsight's first awareness of the explant was (b)(6) 2020).

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT; 100 columbia; aliso viejo, ca
• MDR Report Key: 10308212
• Report Number: 3012712027-2020-00010
• Device Sequence Number: 13654291
• Product Code: HQL
• UDI-Device Identifier: 00818806020203
• UDI-Public: 010081880602020317220131
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: L02-000936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/22/2020
• 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