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	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with bilateral light adjustable lenses implanted.Patient reported a decrease in acuity 24-48 hours prior to lock-in.Patient reported an incident where uv spectacles came off while boating.Slit lamp revealed central premature photopolymerization of the lenses.The lens in the right eye was explanted on (b)(6) 2020 (rxsight became aware on 7/21/2020) while the left eye was explanted on (b)(6) 2020 (rxsight became aware on 7/28/2020).Device history record for both lenses (serial numbers (b)(4) for the left eye and (b)(4) for the right eye) were reviewed.No issues were noted.For lens serial number (b)(4) (left eye): implanted: (b)(6) 2020.Explanted: (b)(6) 2020.Udi: (b)(4).Manufactured: 04/04/2019.Expiration date: 03/31/2022.For lens serial number (b)(4) (right eye): implanted: (b)(6) 2020.Explanted: (b)(6) 2020.Udi: (b)(4).Manufactured: 06/24/2019.Expiration date: 05/31/2022.Both lenses were returned for evaluation.Inspection and evaluation of the lenses confirmed the presence of a zone on the anterior surface on both lensese.The zones are indicative of premature photopolymerization.The incident where the uv spectacles came off outdoors resulted in the premature photopolymerization.
Event or Problem Description
Patient with bilateral light adjustable lenses implanted.Patient reported a decrease in acuity 24-48 hours prior to lock-in.Patient reported an incident where uv spectacles came off while boating.Slit lamp revealed central premature photopolymerization of the lenses.The lens in the right eye was explanted on (b)(6) 2020 (rxsight became aware on 7/21/2020) while the left eye was explanted on (b)(6) 2020 (rxsight became aware on 7/28/2020).

• 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: 10422424
• Report Number: 3012712027-2020-00014
• Device Sequence Number: 11507158
• Product Code: HQL
• UDI-Device Identifier: 00818806020074
• UDI-Public: 010081880602007417220331
• 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): 08/18/2020

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: 03/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001057, L02-001150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/18/2020
• 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