Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL13.2
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found a torn haptic (torn piece is missing).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that a 13.2 mm micl13.2, -11.5 diopter, implantable collamer lens tore during the loading process.There was no patient contact and the backup lens was used with no issues.Cause of event was unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7682694
Report Number2023826-2018-01021
Device Sequence Number600922
Product Code MTA
UDI-Device Identifier00841542103329
UDI-Public00841542103329
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/13/2018
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 Health Professional
Device Expiration Date09/30/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2018
Initial Report FDA Received Date07/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-