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

Model Number PSCST30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The cartridge is not an implantable device; therefore, not explanted.A complete catalog # is unknown, as product lot number was not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after the doctor implanted an intraocular lens (iol) into the patient's left eye, he noticed that there was a small piece of plastic in the eye.The doctor was able to remove it with no harm to the patient.The doctor felt like the piece of plastic came from the cartridge as it was not attached to the iol.There was no incision enlargement.The patient has recovered.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on 11/07/2017.Device returned to manufacturer?: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection showed the cartridge with a particle attached to it.Ftir analysis: foreign material was submitted for analysis by fourier transform infrared (ftir) spectroscopy in order to identify the material.A photo which accompanied the sample confirmed the particle of interest.Ftir analysis of the foreign material shows that it is consistent with polycarbonate.Based on the assessment the cartridges do not have exposure to this type of material during manufacture and the laboratory results do not match any of the product material.Throughout the manufacturing processes there are various controls in place to identify the presence of this type of particle during the inspection controls as part of the manufacturing process.Labeling review: the directions for use (dfu) was reviewed.The 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 or malfunction.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6905831
• MDR Text Key: 87870594
• Report Number: 2648035-2017-01772
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• 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
• Patient Age: 74 YR