MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SILVER; SURGICAL ADJUNCTS

Model Number PSCST30

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that while loading an intraocular lens (iol) into the cartridge, the surgeon observed that the tip of the cartridge was deformed.Reportedly the operation was completed safely.No patient injury reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 10/18/2016.Device returned to manufacturer? yes.Device evaluation: although the customer initially reported one cartridge with the tip deformed, four cartridges were returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed some residues of what appears to be viscoelastics on the returned cartridges.Stress marks in both sides of the cartridge tube and tip was observed which are typically caused and/or may well appear by the pass of the intraocular lens through the cartridge.The cartridge tip was deformed.The customer's reported issue of tip deformed was verified on the four returned cartridges.Manufacturing records review: the lot numbers were not available 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 was verified.Four mdrs will be submitted as four cartridges with the tip deformed were reported.This is 1 of 4.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: SILVER
• Type of Device: SURGICAL 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 Key: 5945369
• MDR Text Key: 54527020
• Report Number: 2648035-2016-01443
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

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 Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• 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 Sequence Number: 1