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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number VTICMO12.6
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2019
Event Type  malfunction  
Manufacturer Narrative
This product is not marketed in the us.(b)(4).
 
Event Description
The reporter indicated that a 12.6mm, vticmo12.6, -8.5/1.0/108 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.The lens was removed within the same surgery due to excessive vault.On (b)(6) 2019 a replacement lens of shorter length was implanted.It was reported that the problem resolved.
 
Manufacturer Narrative
H3 - device evaluation: lens was returned in a micro-centrifuge vial with moisture and residue on the lens.Visual inspection found no visible damage to the lens and residue on the lens.Claim#: (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key10429503
MDR Text Key203815522
Report Number2023826-2020-01793
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberVTICMO12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/20/2020
Supplement Dates Manufacturer Received11/20/2020
Supplement Dates FDA Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
Patient Age25 YR
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