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

Model Number EMERALDC30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

On (b)(6) 2016, it was reported by the physician that there continues to be faint and short "brush stroke type" marks on the intraocular lens (iol) posterior surface of the optic, near the leading haptic/optic junction.They are always in the same place and they occur on most of the iols this customer implants.Reportedly, the marks are only noticeable after the lens is in the bag.The physician can't see the marks when he inspects the lens before loading the cartridge.He thinks the cartridge is the culprit and the new cartridges have a slightly narrower cannula perhaps or an internal edge at the opening.The marks are more noticeable on the higher powered lenses.The marks are visually inconsequential to the patient and no explants are planned since they are well outside the visual axis.No further information was provided.

Manufacturer Narrative

Device evaluation: complaint device was not returned to the manufacturer for investigation.Therefore, the reported issue of cartridge tip damaged could not be verified.The manufacturing records evaluation and the search for same/similar issue could not be performed since the device lot number was not provided.During manufacturing process, all cartridges are inspected and accepted per the inspection criteria.A historical complaint data review was performed and results did not identify any product deficiency.A search within global quality management system was performed and there were no related deviations or non-conformity.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 historical complaint review, non-conformance review and labeling review, there is no indication of a malfunction or product 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 1408; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5498192
• MDR Text Key: 40247474
• Report Number: 2648035-2016-00373
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 06/17/2016

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 Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• 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