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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 Break (1069)
Patient Problem No Code Available (3191)
Event Date 07/30/2018
Event Type  Injury  
Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -12.5/+1.5/036 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to the lens tore/broke during delivery into the eye.There was no patient injury.The lens was exchanged for another same model/length lens and the problem was resolved.The cause of the event was unknown.
 
Manufacturer Narrative
Device evaluation:lens returned in a microcentrifuge vial with moisture on the lens.Visual inspection found haptic torn.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 91016
MDR Report Key9241885
MDR Text Key163961646
Report Number2023826-2019-01958
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 09/28/2019
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
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberVTICMO12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Initial Date Manufacturer Received 09/28/2019
Initial Date FDA Received10/25/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age18 YR
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