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

Model Number EMERALDC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, not provided.Expiration date and unique identifier (udi#): unknown, because the lot number was not provided.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)(4).Device manufacture date: unknown, because the lot number was not provided.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection showed the cartridge tip was deformed.A dent or a smash condition was observed on the tip.No stress marks were observed.The customer's reported complaint was verified.Manufacturing records review: the lot number is unknown; therefore the manufacturing records for the intraocular lens could not be reviewed.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 before the implantation of an intraocular lens (iol), the surgeon observed that the tip of the cartridge was deformed.Reportedly, the cartridge was not used.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: 6702225
• MDR Text Key: 79666648
• Report Number: 2648035-2017-01246
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2017

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 Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/11/2017
• 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
• Treatment: IOL, MODEL AND SERIAL NUMBER UNKNOWN