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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL13.2
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/28/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in the lens vial.Visual inspection found a piece of the haptic missing.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
Reportedly, while preparing to insert a 13.2mm micl13.2, diopter -16.0 implantable collamer lens into the patient's left (os) eye, the lens tore.This was discovered after the loading proces.Reporter states they are unsure as to whether the lens was received damaged or if it tore during loading.There was no patient contact with this lens.This occurred on (b)(6) 2017.
 
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Brand Name
IMPLANTABLE COLLAMER LENS
Common Device Name
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key7281443
Report Number2023826-2018-00251
Device Sequence Number1212554
Product Code MTA
UDI-Device Identifier00841542103411
UDI-Public00841542103411
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/25/2018
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 Physician
Device Expiration Date09/30/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2018
Initial Report FDA Received Date02/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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