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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 VICMO 12.6
Device Problems Misfocusing (1401); Off-Label Use (1494)
Patient Problem Blurred Vision (2137)
Event Date 01/08/2024
Event Type  malfunction  
Manufacturer Narrative
H6-device code 1494: off-label use (under 21yrs of age at date of implant).(b)(4).
 
Event Description
The reporter indicated that a 12.6mm vicmo 12.6 implantable collamer lens of -14.00 diopter was implanted as an exchange lens into the patient's left eye (os) on (b)(6) 2024 to correct refractive change over time.The problem was not resolved.The lens remains implanted.It is noted that the doctor recommends laser corrective surgery for this patient.If additional information is received a supplemental medwatch report will be submitted.See mfr# 2023826-2024-00902 for initial lens.
 
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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 Key18811955
MDR Text Key336627218
Report Number2023826-2024-00903
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeCH
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 01/29/2024
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 NumberVICMO 12.6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/29/2024
Date Device Manufactured05/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age18 YR
Patient SexFemale
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