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	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with a light adjustable lens in the right eye reported blurry vision, glare, and dryness.Upon examination, a central island was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020.The explanted lens is in process of being returned.Device history record for the lens was reviewed.No issues were noted with the device history record.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Patient with a light adjustable lens in the right eye reported blurry vision, glare, and dryness.Upon examination, a central island was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020.The explanted lens is in process of being returned.
Additional Manufacturer Narrative
Half of the lens was returned on (b)(6) 2020.The lens was noted to be cut through the center of the optic and was not in a condition for further evaluation.
Event or Problem Description
Patient with a light adjustable lens in the right eye reported blurry vision, glare, and dryness.Upon examination, a central island was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020.The lens was sent back for evaluation, however the lens has not been received.
Additional Manufacturer Narrative
Patient with a light adjustable lens in the right eye reported blurry vision, glare, and dryness.Upon examination, a central island was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020.The lens was sent back for evaluation, however the lens has not been received.

• 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: 10124048
• Report Number: 3012712027-2020-00006
• Device Sequence Number: 3611289
• Product Code: HQL
• UDI-Device Identifier: 00818806020234
• UDI-Public: 010081880602023417220630
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2020

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: L02-001171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 05/06/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/04/2020; 10/13/2020
• 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