IMPLANTABLE COLLAMER LENS (ICL) TMICL13.2 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for IMPLANTABLE COLLAMER LENS (ICL) TMICL13.2 NA manufactured by Staar Surgical Company.

MAUDE Entry Details

Report Number2023826-2020-00654
MDR Report Key9880944
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-25
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2018-10-31
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CYNTHIA THAI
Manufacturer Street1911 WALKER AVENUE
Manufacturer CityMONROVIA, CA
Manufacturer CountryUS
Manufacturer Phone3037902237
Manufacturer G1STAAR SURGICAL COMPANY
Manufacturer Street1911 WALKER AVENUE
Manufacturer CityMONROVIA, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPLANTABLE COLLAMER LENS (ICL)
Generic NamePHAKIC TORIC INTRAOCULAR LENS
Product CodeQCB
Date Received2020-03-25
Returned To Mfg2020-03-19
Model NumberTMICL13.2
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTAAR SURGICAL COMPANY
Manufacturer Address1911 WALKER AVENUE MONROVIA, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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