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 SEE H10; 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 SEE H10; INTRAOCULAR LENS Back to Search Results
Model Number CQ2015A
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens no similar complaint type events were reported for units within the same lot.Lens was returned in liquid, in vial.Visual inspection found a torn haptic.(b)(4).
 
Event or Problem Description
The reporter indicated that a haptic of cq2015a +21.5 diopter, intraocular lens bent during loading.There was no patient contact and the backup lens was used.Cause of event was unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SEE H10
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key7770170
Report Number2023826-2018-01183
Device Sequence Number16735804
Product Code HQL
UDI-Device Identifier00841542102018
UDI-Public00841542102018
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P990013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/10/2018
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 Date04/30/2019
Device Model NumberCQ2015A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2018
Initial Report FDA Received Date08/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-