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 TORIC 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 TORIC INTRAOCULAR LENS Back to Search Results
Model Number TMICL13.2
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.(b)(4).
 
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -10.50/2.5/070 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.Lens rotation not associated to a low vault was observed, the lens was removed and exchanged for a spherical lens on (b)(6) 2019.This resolved the problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key9565442
Report Number2023826-2020-00007
Device Sequence Number19549741
Product Code QCB
UDI-Device Identifier00841542109116
UDI-Public00841542109116
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
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 12/10/2019
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 Date09/30/2020
Device Model NumberTMICL13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2019
Initial Report FDA Received Date01/08/2020
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;
-
-