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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 02/15/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Secondary surgical intervention, repositioning, explant and exchange for a shorter lens.Claim # (b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm micl13.2, -10.5 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2018.The lens was removed on (b)(6) 2018 due to observation of excessive vault with glare/haloes and blurred vision.It was reported that the lens was repositioned but it did not resolve the problem.On (b)(6) 2018 the lens was exchanged for a shorter length lens and the problem was resolved.
 
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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 Key7470285
Report Number2023826-2018-00623
Device Sequence Number114035
Product Code MTA
UDI-Device Identifier00841542103305
UDI-Public00841542103305
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
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/29/2018
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 Date07/31/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/29/2018
Initial Report FDA Received Date04/27/2018
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;
Patient Age39 YR
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