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

Model Number EMERALDC30

Device Problems Burst Container or Vessel (1074); Crack (1135); Split (2537); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Implant and explant date: if implanted or explanted, give date: not applicable as this is not an implantable device concomitant medical product(s): za9003 lens, serial number (b)(4); healon 0.85, lot number ub32157.Initial reporter phone# (b)(6).(b)(4).Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residues of viscoelastic solution (ovd) on the cartridge which indicated that the unit was handled and prepare for surgical use.Dent/distortion and a crack with the sharp barb were observed at the cartridge tip area.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During the manufacturing process the operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.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.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that as the surgeon was ready to inject the intraocular lens (iol) into the patient's eye, he noted a sharp barb on the tip of the cartridge.Reportedly the sharp barb could have not been seen with the naked eye while loading the lens.Additional information was received and it was learnt that the cartridge's tube stretched and burst open on advancing the lens into the eye.The procedure was completed with no patient injury or additional intervention.No further information was provided.

Manufacturer Narrative

Corrected data: on the initial mdr a crack was noted in the device evaluation description provided in section, however device code was not included in section.It has been included in this submission.Additional information: device evaluation: upon further review of the device evaluation in addition to the previously reported sharp barb and crack, a large split (crack) was observed at the cartridge tip area.(b)(4).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: 6149720
• MDR Text Key: 61593922
• Report Number: 2648035-2016-01947
• 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: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• 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