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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 VTICH_13.2
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
H6 - health effect clinical code: 4581 - loss of bcva, reduced contrasts at night.H6 - medical device problem code - 1494: off-label use - amblyopia.Claim#: (b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm vtich13.2, +2/+1.5/075 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2022.The surgeon reports the patient now has loss of bcva and blurred vision, headaches and reduced contrast at night.Lens remains implanted.The cause of the event was reported as unknown.
 
Manufacturer Narrative
B5 - on day one post-op the ucva was reported as 0.9 and 'pressure increase le' was reported which was managed by'"extra yag iridotomy le after which pressure normal'.Early elevated iop was reported.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 Key17882131
MDR Text Key325091922
Report Number2023826-2023-04444
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
Reporter Country CodeBE
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,Followup
Report Date 09/21/2023
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? Yes
Device Operator Health Professional
Device Model NumberVTICH_13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2023
Initial Date FDA Received10/05/2023
Supplement Dates Manufacturer Received12/18/2023
Supplement Dates FDA Received12/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2022
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
CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
Patient Outcome(s) Required Intervention;
Patient SexMale
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