• 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 ICL (IMPLANTABLE COLLAMER LENS); 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 ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS Back to Search Results
Model Number MICL12.6
Device Problems Positioning Failure (1158); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
Visual inspection of the returned product found one haptic torn, with pieces torn off and missing.The lens was returned in liquid.(b)(4).
 
Event Description
The reporter stated the surgeon was inserting a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, and noted the lens was damaged.The lens was partially inserted and was removed with no patient injury.The backup lens was implanted.The reporter stated the lens may not have been pulled down the cartridge barrel enough and the foam tip plunger caught and damaged the lens.The reporter stated the cause of the event was due to user error.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ICL (IMPLANTABLE COLLAMER LENS)
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
michelle andres
1911 walker avenue
monrovia, CA 91016
6263037902
MDR Report Key6064990
MDR Text Key58717086
Report Number2023826-2016-01560
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00841542102995
UDI-Public(01)00841542102995(17)180430
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/13/2016
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
Device Operator Physician
Device Expiration Date04/30/2018
Device Model NumberMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2016
Initial Date FDA Received10/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
Patient Age36 YR
-
-