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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 VTICMO13.2
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Headache (1880); Pain (1994); No Code Available (3191)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
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 13.2mm vticmo13.2 implantable collamer lens, -4.00/+4.0/033 (sphere/cylinder/axis) in the patient's left eye (os), on (b)(6) 2018.The reporter indicated the lens had excessive vaulting and the patient experienced severe headache.The reporter indicated the related symptom may be due to shallow anterior chamber (mid peripheral iridocorneal touch in turn causing headache and eye pain).The lens remains implanted.The reporter stated the cause of the event is the device.
 
Manufacturer Narrative
The reporter indicated the lens was explanted on (b)(6) 2018.The lens was exchanged for a shorter lens and the problem was resolved.(b)(4).
 
Manufacturer Narrative
The exchange lens did not resolve the issue.Reference mfr report # 2023826-2019-00435 for further details on the exchange lens.Common device name should be corrected to phakic toric intraocular lens in original mdr.Claim#: (b)(4).
 
Manufacturer Narrative
Additional data device evaluation- the lens was returned dry in a microcentrifuge vial.Visual inspection found blue residue on lens surface and no visible damage to 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 91016
MDR Report Key8182322
MDR Text Key130974467
Report Number2023826-2018-01885
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,Followup,Followup
Report Date 11/26/2018
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 Date08/31/2021
Device Model NumberVTICMO13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received12/24/2018
02/25/2019
02/18/2019
Supplement Dates FDA Received01/18/2019
02/25/2019
06/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL SFC-45 - LOT # 1396843; FOAM TIP PLUNGER MODEL FTP - LOT #1398794; INJECTOR MODEL MSI-PF - LOT # UNK
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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