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

Model Number EMERALDC30

Device Problem Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that two cartridges had a jagged edge so the intraocular lenses could not be loaded into them.Reportedly, the tip of the cartridges were not smooth and had a slight dent in them.No patient involvement was reported.The lenses were reloaded using different cartridges.No further information was provided.Two reports will be filed to record the two cartridges.This mdr is for report 1 of 2.

Manufacturer Narrative

Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators inspect the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 05/15/2017.Device returned to manufacturer? yes.Device evaluation: two cartridges were returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the cartridge tips were deformed.Evidence of viscoelastic residue, ovd (ophthalmic viscosurgical device) was observed in the two cartridge tubes, tips, and loading zones, indicating that the devices were handled and prepared for surgical use.The customer's reported complaint was verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: EMERALD
• 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: 6571501
• MDR Text Key: 75308084
• Report Number: 2648035-2017-00884
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)170620(10)CB34568
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2017

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 Expiration Date: 06/20/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CB34568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: Not provided; 06/21/2017
• Supplement Dates FDA Received: 06/09/2017; 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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