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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 13.7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blurred Vision (2137)
Event Date 03/19/2024
Event Type  malfunction  
Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
 
Event Description
The reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -9.50 diopter was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault and pain with headaches have been reported.The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
 
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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
MDR Report Key19177597
MDR Text Key341516765
Report Number2023826-2024-01865
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00840311301256
UDI-Public00840311301256
Combination Product (y/n)N
Reporter Country CodeFR
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 03/28/2024
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 NumberVICM5 13.7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/24/2024
Date Device Manufactured10/07/2022
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# 1592707; FOAM TIP PLUNGER (FTP), LOT# 1587623
Patient SexFemale
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