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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 VTICH12.6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
The reporter indicated that a 12.6mm vtich12.6 implantable collamer lens of 2.00/3.5/094 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2024.On (b)(6) 2024 the lens was repositioned due to lens rotation not associated to a low vault but it did not resolve the problem.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
 
Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.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 SUGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene muniz
1911 walker avenue
monrovia, CA 91016
MDR Report Key19218467
MDR Text Key341457855
Report Number2023826-2024-02026
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
Reporter Country CodeNL
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
Type of Report Initial
Report Date 04/08/2024
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 NumberVTICH12.6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/06/2023
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
INJECTOR MODEL: MSI-PF, LOT# UNK.
Patient Outcome(s) Required Intervention;
Patient SexMale
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