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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 Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Doctor noted after several ldd treatments that the light adjustable lens was implanted backwards into the patient's right eye.The lens was explanted and replaced with another light adjustable lens on (b)(6) 2021.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned for evaluation.Visual inspection and optical testing verified that the lens had not been affected by the light treatments due to being implanted backwards.
 
Event or Problem Description
Doctor noted after several ldd treatments that the light adjustable lens was implanted backwards into the patient's right eye.The lens was explanted and replaced with another light adjustable lens on (b)(6) 2021.
 
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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 Key12064184
Report Number3012712027-2021-00024
Device Sequence Number3502687
Product Code PZK
UDI-Device Identifier00818806020104
UDI-Public01008188060201041119121517221130
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P160055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/24/2021
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 NumberL02-001479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/01/2021
Initial Report FDA Received Date06/24/2021
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 Other;
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