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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 MICL13.2
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned in a specimen cup with moisture on the lens.There was clear surgical residue/debris on the product and lens surface.Visual inspection found no visible damage to the lens.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2 implantable collamer lens, -5.0 diopter, into the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017 the lens was exchanged for a longer lens due to "malfunctioning icl with low vault.".
 
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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 Key7201636
Report Number2023826-2018-00084
Device Sequence Number19093391
Product Code MTA
UDI-Device Identifier00841542103190
UDI-Public00841542103190
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/22/2017
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? No
Operator of Device Physician
Device Expiration Date08/31/2018
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2017
Initial Report FDA Received Date01/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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