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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 VICM512.6
Device Problem No Apparent Adverse Event (3189)
Patient Problems Corneal Edema (1791); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
 
Event Description
The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of a -9.0 was implanted as a replacement lens into the patient's left eye (os) on (b)(6) 2023.Mild edema was reported.
 
Manufacturer Narrative
B5: the problem was resolved.Claim# (b)(4).
 
Manufacturer Narrative
It was later reported "eye is quiet and no edema.Pt vision is 6/6".Claim# (b)(4).
 
Manufacturer Narrative
Corrected data: h6-health effect- clinical code: "1791" should be added.B5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -9.00 into the patient's left eye (os) on (b)(6) 2023 as a replacement lens.The patient experienced a mild edema.The lens remains implanted and the problem was resolved.Claim# (b)(4).
 
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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
800 royal oaks dr. suite: 210
monrovia, CA 91016
8002927902
MDR Report Key18504002
MDR Text Key332797584
Report Number2023826-2024-00204
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00840311300587
UDI-Public00840311300587
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup,Followup
Report Date 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVICM512.6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2024
Initial Date FDA Received01/12/2024
Supplement Dates Manufacturer Received01/16/2024
01/15/2024
02/19/2024
Supplement Dates FDA Received01/16/2024
01/23/2024
02/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2023
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
UNK.
Patient SexMale
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