IMPLANTABLE COLLAMER LENS (ICL) VTICM5_12.6 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-23 for IMPLANTABLE COLLAMER LENS (ICL) VTICM5_12.6 N/A manufactured by Staar Surgical Company.

Event Text Entries

[188877899] The product is manufactured in the us, but not marketed in the us. (b)(4). No similar complaint type events reported for units within the same lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188877900] The reporter indicated the surgeon implanted a 12. 6mm vticm5_12. 6 implantable collamer lens, -6. 5/+4. 0/094 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2019. On (b)(6) 2020 the lens was exchanged with a longer length lens due to the patient was "dissatisfied with the quality of his vision. " the problem is resolved. The cause of the event is reported as device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2023826-2020-00617
MDR Report Key9869334
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-23
Date of Report2020-03-03
Date of Event2020-02-02
Date Mfgr Received2020-03-03
Device Manufacturer Date2018-02-06
Date Added to Maude2020-03-23
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 Phone2927902237
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 Received2020-03-23
Model NumberVTICM5_12.6
Catalog NumberN/A
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTAAR SURGICAL COMPANY
Manufacturer Address1911 WALKER AVENUE MONROVIA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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