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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_12.1
Device Problem Unintended Movement (3026)
Patient Problem Corneal Edema (1791)
Event Date 09/28/2023
Event Type  Injury  
Manufacturer Narrative
H6 - type of investigation: 4110 - 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 the surgeon implanted a 12.1mm vicm5_12.1; -4.00 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The lens was implanted upside down.Intraoperatively the lens was removed with patient' injury - as corneal edema occurred after the lens was removed and the patient decided they did not want to wear icls.The problem was resolved.The cause of the event was reported as unknown.
 
Manufacturer Narrative
Corrected data: h6- health effect - impact code: "2199" should be removed and "4614" should be added.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 SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene muniz
1911 walker avenue
monrovia, CA 91016
MDR Report Key18007847
MDR Text Key326706736
Report Number2023826-2023-04805
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/24/2023
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 NumberVICM5_12.1
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 10/24/2023
Initial Date FDA Received10/25/2023
Supplement Dates Manufacturer Received01/31/2024
Supplement Dates FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2023
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 Outcome(s) Other;
Patient Age33 YR
Patient SexFemale
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