MAUDE Adverse Event Report: RXSIGHT, INC. 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	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with bilateral light adjustable lens implants presented during a preadjustment visit with decreased best corrected visual acuity (20/60 in right eye, 20/100 in left eye).Family member present indicated that patient was not compliant with uv spec wear during waking hours.Both lenses were explanted: right eye explanted on (b)(6) 2020 - the lens was discarded at the site; the left eye was explanted on (b)(6) 2020 and is pending return for evaluation.Manufacturer became aware on (b)(6) 2020.The explanted lens from the left eye is 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 7/27/2019.Expiration date was 6/30/2022.Udi: (b)(4).Lens serial number (b)(4) was implanted into the left eye.Manufacturing date of 10/7/2019.Expiration date was 9/30/2022.Udi: (b)(4).
Event or Problem Description
Patient with bilateral light adjustable lens implants presented during a preadjustment visit with decreased best corrected visual acuity (20/60 in right eye, 20/100 in left eye).Family member present indicated that patient was not compliant with uv spec wear during waking hours.Both lenses were explanted: right eye explanted on 4/16/2020 - the lens was discarded at the site; the left eye was explanted on 5/5/2020 and is pending return for evaluation.
Additional Manufacturer Narrative
The explanted lens from the left eye was returned for evaluation and received on june 24, 2020.The lens had been cut into two pieces as it had been cut to explant.Visual inspection confirmed the presence of a large zone in the center of the lens, which is indicative of unanticipated polymerization of the lens.An optical path difference also confirmed the central zone.Test results confirmed the unanticipated polymerization as a result of patient non-compliance to uv spectacle wear.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 10047901
• Report Number: 3012712027-2020-00004
• Device Sequence Number: 19024143
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 010081880602022717220630
• 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): 05/12/2020

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: L02-001204, L02-001343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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