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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 VTICM5_12.1
Device Problem Optical Problem (3001)
Patient Problems Headache (1880); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/13/2023
Event Type  Injury  
Event Description
The reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1, -11.0/1.5/080 (sphere/cylinder/axis), implantable collamer lens, into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2023 the lens was explanted due to glare/halos, headache, and patient disstatisfaction.Problem resolved.
 
Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
 
Manufacturer Narrative
Corrected data: h6-health effect- clinical code: "4581- patient dissatisfaction" should be added.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
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene muniz
1911 walker avenue
monrovia, CA 91016
MDR Report Key17986875
MDR Text Key326295043
Report Number2023826-2023-04601
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 10/04/2023
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 Model NumberVTICM5_12.1
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received10/23/2023
Supplement Dates Manufacturer Received01/25/2024
Supplement Dates FDA Received01/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK.
Patient Outcome(s) Required Intervention;
Patient Age39 YR
Patient SexFemale
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