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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)
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RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL) Back to Search Results
Model Number 60005
Medical Device Problem Code Optical Problem (3001)
Health Effect - Clinical Code Visual Impairment (2138)
Date of Event 11/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Site reported that the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event occurred on 11/30/2020.Device history record for the lens was reviewed.No issues were noted.The explanted lens was discarded at the site and is not expected to be returned.
 
Event or Problem Description
Site reported that the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event occurred on 11/30/2020.
 
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Brand Name
LIGHT ADJUSTABLE LENS (LAL)
Common Device Name
LIGHT ADJUSTABLE LENS (LAL)
Manufacturer (Section D)
RXSIGHT, INC.
100 columbia
aliso viejo CA 92656
MDR Report Key11051035
Report Number3012712027-2020-00043
Device Sequence Number2651716
Product Code PZK
UDI-Device Identifier00818806020135
UDI-Public01008188060201351119120517221130
Combination Product (Y/N)N
Initial Reporter StateSD
Initial Reporter CountryUS
PMA/510(K) Number
P160055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 12/21/2020
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 Date11/30/2022
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-001447
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/30/2020
Initial Report FDA Received Date12/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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