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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 Optical Problem (3001)
Health Effect - Clinical Codes Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event 07/16/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lens was returned in liquid, in a specimen cup.Visual inspection found no visible damage to the lens.(b)(4).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 13.2mm micl13.2 implantable collamer lens, -9.5 diopter, into the patient's left (os) eye on (b)(6) 2019.On (b)(6) 2019 the surgeon explanted the lens due to glare and halos.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 Key8912824
Report Number2023826-2019-01501
Device Sequence Number1658460
Product Code MTA
UDI-Device Identifier00841542103282
UDI-Public00841542103282
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/25/2019
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 Health Professional
Device Expiration Date04/30/2020
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2019
Initial Report FDA Received Date08/20/2019
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 Age35 YR
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