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	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with bilateral light adjustable lens implants on (b)(6) 2020 without issue.Patient reported blurred vision on (b)(6) 2020.Premature photopolymerization detected.Patient reported 75% compliance with wearing uv protective eyewear (treatments were delayed due to covid-19).Both lenses were explanted: right eye explanted on (b)(6) 2020 (rxsight's first awareness was 5/20/2020).Left eye was explanted on (b)(6) 2020.Both lenses are pending return for evaluation.Both explanted lenses are in process of being returned for evaluation.Device history record for the lenses were reviewed.No issues were noted with the device history records.Lens serial number (b)(4) was implanted into the right eye.Manufacturing date of 2/20/2019.Expiration date was 1/31/2022.Udi: (b)(4).Lens serial number (b)(4) was implanted into the left eye.Manufacturing date of 2/23/2019.Expiration date was 1/31/2022.Udi: (b)(4).
Event or Problem Description
Patient with bilateral light adjustable lens implants on (b)(6) 2020 without issue.Patient reported blurred vision on (b)(6) 2020.Premature photopolymerization detected.Patient reported 75% compliance with wearing uv protective eyewear (treatments were delayed due to covid-19).Both lenses were explanted: right eye explanted on (b)(6) 2020 (rxsight's first awareness was 5/20/2020).Left eye was explanted on (b)(6) 2020.Both lenses are pending return for evaluation.
Additional Manufacturer Narrative
Both lenses were returned for evaluation.Inspection and evaluation of the lenses confirmed the presence of a zone on the anterior surface on both lenses.The zones are indicative of premature photopolymerization.As light treatments were delayed due to covid-19 interruption of clinical services, prolonged wear of the uv spectacles was required.The patient did not maintain full compliance (patient reported 75% compliance) with wearing uv protective eyewear.

• 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: 10164837
• Report Number: 3012712027-2020-00007
• Device Sequence Number: 14109773
• Product Code: HQL
• UDI-Device Identifier: 00818806020173
• UDI-Public: 010081880602017317220131
• 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,Followup
• Report Date (Section B): 06/17/2020

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: L02-000954, L02-000957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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