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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 Codes No Apparent Adverse Event (3189); Ejection Problem (4009)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lens was returned dry in lens vial, wlith residue on lens.Visual inspection found the lens optic and haptic torn.No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated while the surgeon was inserting a 13.2mm micl13.2 implantable collamer lens, - 8.0 diopter, the foam tip plunger overrode the lens and while trying to disengage, the lens was ripped.There was patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
 
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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
MDR Report Key9747629
Report Number2023826-2020-00318
Device Sequence Number1974996
Product Code MTA
UDI-Device Identifier00841542103251
UDI-Public00841542103251
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/03/2020
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 Date01/31/2021
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date02/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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