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	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bilateral patient reported to have spent time outdoors without uv protective eyewear resulting in decreased visual acuity due to premature photopolymerization of both lenses.Right eye (implanted (b)(6) 2020) was explanted on (b)(6) 2020.Left eye (implanted (b)(6)2020) was explanted on (b)(6) 2020.Rxsight's first awareness date was (b)(6) 2020.Device history record for both lenses (serial numbers (b)(4) for the right eye and (b)(4) for the left eye) were reviewed.No issues were noted.For lens serial number (b)(4) (right eye), implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 3/19/2019, expiration date: 2/28/2022.For lens serial number (b)(4) (left eye), implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 5/17/2019, expiration date: 4/30/2022.The site visually confirmed the premature photopolymerization of the lenses through slit lamp examination.The site noted that the explanted lenses were too fragmented to be returned.
Event or Problem Description
Bilateral patient reported to have spent time outdoors without uv protective eyewear resulting in decreased visual acuity due to premature photopolymerization of both lenses.Right eye (implanted (b)(6) 2020) was explanted on (b)(6) 2020.Left eye (implanted (b)(6)2020) was explanted on (b)(6) 2020.Rxsight's first awareness date was (b)(6) 2020.

• 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: 10653303
• Report Number: 3012712027-2020-00024
• Device Sequence Number: 14256971
• Product Code: HQL
• UDI-Device Identifier: 00818806020258
• UDI-Public: 010081880602025817190319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/08/2020

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: 02/28/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/08/2020
• 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