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

Model Number EMERALDC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

The cartridge is not an implantable device; therefore, not explanted.(b)(6).Device evaluation: the product was discarded by the customer.Two unused emeraldc30 cartridges were returned for investigation.Visual inspection at 10x microscope magnification was performed.No damage and/or defect was observed on the returned units.In addition, photos provided by the customer were evaluated.Photos 1 and 2 debris was observed at the edge of the iol during implantation.Photo 3: photo showed the loading zone area of the cartridge.No damage was observed in this area.Based on the evidence observed, it is not possible to confirm if the foreign material observed in the photos is related to manufacturing, as the reported device was handled and prepared for surgical use.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) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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.

Event Description

It was reported that there was some debris that came out from the emeraldc cartridge with the intraocular lens (iol) during iol implantation.The surgeon removed the debris from the eye.There was no patient injury but there was a 2-minute delay in surgery.The device was discarded.No additional information was provided to abbott medical optics.

Manufacturer Narrative

The surgeon reported a burr at the cartridge edge.The investigation site revisited the investigation and reported the following: the burr at the edge of the cartridge reported by complaint owner is a flash.According to drawing p/n: 192216 (emerald c cartridge molded), rev.F (note 8 and 11), dimension inspection on parting lines is required: 0.030 flash is allowable on parting lines not interfering with closure.All pertinent information available to johnson and johnson surgical vision, inc.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7278740
• MDR Text Key: 100515860
• Report Number: 2648035-2018-00254
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)180322(10)CC03493
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/22/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CC03493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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: 90 YR