IMPLANTABLE COLLAMER LENS (ICL) VTICM5_12.6 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-25 for IMPLANTABLE COLLAMER LENS (ICL) VTICM5_12.6 NA manufactured by Staar Surgical Company.

Event Text Entries

[188881884] This product is manufactured in the u. S. But not marketed in the u. S. (b)(4). No similar complaint was reported for units within the same lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188881885] The reporter indicated the surgeon implanted a 12. 6mm vticm5_12. 6 implantable collamer lens, -11. 50/+2. 0/091 (sphere/cylinder/axis), in the patient's left eye (os), on (b)(6) 2019. The lens was explanted on (b)(6) 2019 due to patient discomfort (due to presbyopia). The lens was exchanged for another same model/length but different diopter lens and the problem was resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2023826-2020-00668
MDR Report Key9881043
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-25
Date of Report2020-03-06
Date of Event2019-04-02
Date Mfgr Received2020-03-06
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
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 Mfg2020-03-18
Model NumberVTICM5_12.6
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
101. Required No Informationntervention 2020-03-25

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