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

Model Number EMERALDC30

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 03/02/2014

Event Type  Injury  

Event Description

It was reported that due to a deformed tip of the cartridge the incision was required to be enlarged in implanting the intraocular lens.

Manufacturer Narrative

Implant explant dates: not applicable: device used to implant intraocular lens.Initial reporter(phone): (b)(6).(b)(4).All pertinent information available to the manufacturer has been submitted.Placeholder.

Manufacturer Narrative

It was reported that surgery was completed successfully with no patient complications.The patient outcome was no problem with recovery.Cm01986 - removing from serial# and adding to lot#.Device evaluation: the cartridge sample was returned for evaluation.Visual inspection under microscope revealed heavy dent/distortion in the cartridge tip area.Residues of viscoelastic (ovd) solution were observed on the cartridge tube only.Event consideration may include operational problem related to loading into insertion handpiece, insertion handpiece rod tip damage or misalignment, insufficient ovd during intraocular lens (iol) loading, or surgical technique.A review of the manufacturing records showed no deviations or nonconformities.The documentation showed that the production order was manufactured according to specifications.A review of the manufacturing process and/or materials changes show there are no associated changes with respect to the order number.No non-conformance (ncr) was generated during the manufacturing process.All pertinent information available to the manufacturer has been submitted.Placeholder.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer Contact: stephanie solomon ; abbott medical optics inc.; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 3703387
• MDR Text Key: 4269104
• Report Number: 2648035-2014-00137
• Device Sequence Number: 1
• Product Code: KYB
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2014

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: 10/25/2014
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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 Outcome(s): Other