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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SILVER SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS SILVER SURGICAL ADJUNCTS Back to Search Results
Model Number PSCST30
Device Problems Difficult or Delayed Positioning; Positioning Failure ; Device Operates Differently Than Expected
Event Date 09/07/2016
Event Type  Malfunction  
Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that an intraocular lens (iol) was loaded into the cartridge without any issue. Reportedly, during the implantation into the eye, the surgeon had difficulties releasing the lens out of the cartridge therefore decided to use the back-up lens. The lens had contact with the patient's eye. Additional information was received and it was confirmed that the haptic had partial contact with the eye; the lens was not fully inserted as it was stuck in the cartridge. There was no patient injury, no incision enlargement, no suture(s) and no vitrectomy. Procedure was completed successfully with a backup lens. No further information was provided.

 
Manufacturer Narrative

Device available for evaluation - yes. Returned to manufacturer on: 10/03/2016. Device returned to manufacturer - yes. Device evaluation: the cartridge was returned at the manufacturing site for evaluation. Visual inspection at 10x microscope magnification shoed evidence of viscoelastic ovd (ophthalmic viscosurgical device) residues inside the cartridge tube, indicating the device was handled and prepared for surgical use. The three piece intraocular lens (iol) was observed stuck in the cartridge. The customer's reported complaint could not be verified. Manufacturing records review: the lot number is unknown; therefore the manufacturing records could not be reviewed. Labeling review: the directions for use (dfu) were reviewed. The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device. As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to abbott medical optics has been submitted.

 
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Brand NameSILVER
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key6002051
Report Number2648035-2016-01552
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberPSCST30
Device Catalogue NumberPSCST30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/03/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/05/2016 Patient Sequence Number: 1
Treatment
Z9002 LENS, SERIAL NUMBER (B)(4)
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