MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); INTRAOCULAR LENS

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient received bilateral light adjustable lens implants (implanted (b)(6) 2019).Patient reported a visual acuity issue for the right eye.The physician elected to explant the lens (explanted on (b)(6) 2020).Right eye bcva with the light adjustable lens noted to be 20/25.No issues were noted with the device history record.The lens was explanted, but the site reported that the lens came out in such small pieces that there was nothing to save and return.No return is expected for this lens.The site noted that the "lal looked fine".The lal was exchanged with another monofocal lens and noted that the patient is very happy.Bcva with lal: 20/25; bcva after the exchange: 20/20.
Event or Problem Description
Patient received bilateral light adjustable lens implants (implanted (b)(6) 2019).Patient reported a visual acuity issue for the right eye.The physician elected to explant the lens (explanted on (b)(6) 2020).Right eye bcva with the light adjustable lens noted to be 20/25.
Event or Problem Description
Bilateral patient previously had right eye explanted on (b)(6) 2020.Lens within the left eye was explanted due to a visual acuity issue on (b)(6) 2020 (rxsight's aware date was (b)(6) 2020).
Additional Manufacturer Narrative
The lens explanted from the left eye was returned for evaluation.Visual inspection of the returned lens found that the lens had been broken up into multiple small fragments.Due to the condition of the lens, no further evaluation could be performed.
Additional Manufacturer Narrative
Bilateral patient previously reported to have lens in right eye explanted on (b)(6) 2020.Lens within the left eye was explanted due to a visual acuity issue on (b)(6) 2020 (rxsight's aware date was (b)(6) 2020).No issues were noted with the device history record for the lens within the left eye.Lens implanted in the left eye: serial number: (b)(6); manufacture date: 06/20/2019; expiration date: 05/31/2022; implant date: (b)(6) 2020; explant date: (b)(6) 2020; udi: (b)(4).The lens in the left eye was explanted and is pending return from the site.
Event or Problem Description
Bilateral patient previously had right eye explanted on (b)(6) 2020.Lens within the left eye was explanted due to a visual acuity issue on (b)(6) 2020 (rxsight's aware 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
• MDR Report Key: 10402350
• Report Number: 3012712027-2020-00013
• Device Sequence Number: 19750881
• Product Code: HQL
• UDI-Device Identifier: 00818806020265
• UDI-Public: 010081880602026517220228
• 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: 2019
• 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): 08/13/2020

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: L02-001003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 07/15/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/27/2020; 11/17/2020
• 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
• Patient Age: 67 YR