Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 07/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Site reported that the light adjustable lens was explanted due to visual disturbances.Rxsight's first awareness of the event was (b)(6) 2021 device history record for the lens was reviewed.No issues were noted.The lens was returned for evaluation.Visual inspection found the lens had been cut into multiple fragments.Only the outer fragments of the lens optic were returned.The central portion of the optic was not found in the return.Optical testing could not be performed due to the condition of the returned lens.
 
Event or Problem Description
Site reported that the light adjustable lens was explanted due to visual disturbances.Rxsight's first awareness of the event was (b)(6) 2021.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12394391
Report Number3012712027-2021-00047
Device Sequence Number11776382
Product Code PZK
UDI-Device Identifier00818806020142
UDI-Public01008188060201421172112312120008810216
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 Year2019
Device Explanted Year2021
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) 08/31/2021
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 Date12/31/2021
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-000881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/10/2021
Initial Report FDA Received Date08/31/2021
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 Required Intervention;
-
-