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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number VICM5 12.6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/22/2024
Event Type  Injury  
Manufacturer Narrative
H6- health effect- clinical code 4581: heaviness in the eye.H6 type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
 
Event Description
The reporter indicated that a 12.6mm vicm5_12.6 implantable collamer lens of -6.00 diopter was implanted into the patient's right eye (od) on (b)(6) 2024.The reporter states that after icl implant the patient felt heaviness in the eye and had the lens explanted on (b)(6) 2024, problem resolved.Cause of event is unknown.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC 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
6263037902
MDR Report Key19217974
MDR Text Key341457614
Report Number2023826-2024-02017
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00840311300525
UDI-Public00840311300525
Combination Product (y/n)N
Reporter Country CodeJA
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 04/05/2024
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 NumberVICM5 12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/29/2023
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
CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
Patient Outcome(s) Required Intervention;
Patient Age36 YR
Patient SexFemale
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