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

Model Number EMERALDC30

Device Problems Break (1069); Crack (1135); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: intraocular lens (iol) za9003 +20.5 diopter, serial number unknown; amo viscoelastic healon, lot number unknown.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during the implantation of an intraocular lens (iol) the surgeon noticed under the microscope that the tip of the cartridge had a deformed shaft and it began to stretch and crack as the lens advanced through it.They heard the cartridge cracking.The cartridge channel broke open inside the patient¿s eye.The surgeon had to use a second instrument to advance the lens into the implant position and also to extract the cartridge.Reportedly, a small piece of particle matter was noticed and was aspirated following the lens implant.There were no adverse effects.No injury to the patient's eye and no surgical or medical intervention was required.The patient's outcome was reported being as expected.No further information was provided.

Manufacturer Narrative

Device evaluation: viscoelastics residues were detected at the cartridge tip.Visual inspection at 10x microscope magnification was performed.Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the passage of the iol through the cartridge.The cartridge tip was deformed.There were no particles / debris detected on the return.The reported issue of ¿deformed cartridge tip¿ was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 6235859
• MDR Text Key: 64242182
• Report Number: 2648035-2017-00046
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)170711(10)CB35883
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/11/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CB35883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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