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

Model Number EMERALDC30

Device Problems Bent (1059); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted; give date: na (not applicable) the cartridge is not an implanted device.Section.If explanted; give date: na (not applicable) the cartridge is not implanted, and therefore not explanted.(b)(4) cartridge seemed too tight.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during handling and not when the product was removed from packaging, the cartridge, model emeraldc, seemed too tight and the lens did not load right.The cartridge and lens were not used and the customer reported perhaps the cartridge tip was bent.Back-up products were used instead.There was no patient contact.No other information was provided.

Manufacturer Narrative

Visual inspection was not performed as the cartridge has not been returned to the manufacturer.The reported complaint cannot be confirmed.Manufacturing records were reviewed and the cartridge was manufactured according to specification.There were no non-conforming reports, discrepancies, and deviations for similar issues were found during the manufacturing record review.The product was manufactured and released according to specification.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the manufacturing records review, historical complaint review and labeling review, there is no indication of a product malfunction or product quality deficiency.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: 5358900
• MDR Text Key: 35613408
• Report Number: 2648035-2016-00048
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

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: 05/07/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CA03403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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