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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 MICL 13.2
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Claim#: (b)(4).
 
Event or Problem Description
The reporter indicated that on (b)(6) 2020 a micl 13.2, -14.0 diopter, implantable collamer lens tore before/during loading.No patient contact.A backup lens was implanted intraoperatively and this resolved the problem.Per reporter on (b)(6) 2020, "patient is doing well.".
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key10678695
Report Number2023826-2020-02355
Device Sequence Number19606524
Product Code MTA
UDI-Device Identifier00841542103374
UDI-Public00841542103374
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 09/22/2020
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
Operator of Device Health Professional
Device Expiration Date04/30/2021
Device Model NumberMICL 13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/22/2020
Initial Report FDA Received Date10/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CARTRIDGE MODEL#SFC-45,LOT#1492562.1; FOAMTIPPLUNGER MODEL#FTP,LOT#1487147.1
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