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

Model Number EMERALDC30

Device Problems Scratched Material (3020); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

This is not an implantable device.(b)(6).(b)(4).Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residue of viscoelastic solution on the cartridge, indicating that the unit was handled and prepare for surgical use.Dent/distortion was observed at the cartridge tip.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 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 investigation requests 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.

Event Description

It was reported that an intraocular lens (iol) was implanted in the eye of a (b)(6) male patient and the cartridge was noticed to have a marking and burr edge.No impact to the patient.Additional information revealed that the issue was located on the cartridge tip.No further information was provided.

• 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: 6645736
• MDR Text Key: 77744592
• Report Number: 2648035-2017-01074
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)170727(10)CB36717
• 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
• Report Date: 06/15/2017

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: 07/27/2017
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CB36717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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
• Patient Age: 58 YR