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

Model Number EMERALDC30

Device Problems Material Deformation (2976); Appropriate Term/Code Not Available (3191)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The suspect product is a cartridge that is not implanted.The suspect product is a cartridge that is not implanted.(the lens remains implanted at the time of submitting the mdr.) (b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was initially reported that the tip of the cartridge was barbed/too sharp.The surgeon continued with the insertion; however, the surgeon was concerned with the lot that they received for any potential injury to the patient.The surgeon also mentioned that the lens imprint on the cartridge (marker of where to put the lens) appeared off.The problem was not related to use error.In follow-up, it was reported that when the lens was being inserted into the patient铠eye, the doctor noticed that the cartridge tip was kind of deformed, appeared to be barbed/sharp hence the doctor was concerned that the patient might get injured.However, the doctor was still able to implant the lens without any problems despite issue with the cartridge.No incision enlargement, no vitrectomy performed, and no patient injury post-operatively.

Manufacturer Narrative

The initial complaint only indicated one cartridge as the complaint device, however two cartridges were received for investigation.Both cartridges were investigated as the complaint device associated with this complaint was not specifically identified.Visual inspection: cartridge #1 viscoelastic (ovd) residue was observed in the cartridge tube, loading zone, and the wings section indicating that unit was handled and prepared for surgical use.The tip was observed deformed, therefore, the reported device problem code was verified.The iol diagram on the cartridge wing was complete and visible.Cartridge #2 the cartridge wings were found folded.Viscoelastic (ovd) residue was observed in the cartridge tube, loading zone, and the wings section indicating that unit was handled and prepared for surgical use.The tip was observed deformed, therefore, the reported device problem code was verified.The iol diagram on the cartridge wing was complete and visible.In summary, the cartridge tips were deformed in the two returned cartridges.Therefore, the issue reported by the customer was verified by visual inspection.The manufacturing records for the cartridges were reviewed.The emeraldc30 cartridge manufacturing process record was evaluated.The cartridges were manufactured within specifications.There were no associated deviations or non-conformity reports found in the manufacturing record review.The device manufacturing procedures were performed as required.During the manufacturing process, the tip of the cartridge is checked for any melting, roughness, dent, bent tip, or smash condition and would not be accepted.A search on complaints related to the production order was conducted and revealed two additional complaints for this lot number have been received.The cartridges reported met specifications prior to release.The directions for use (dfu) was reviewed for the emeraldc30, cartridge.The dfu states if the cartridge tip is cracked or split, do not use.Do not use if the instrument has been dropped or inadvertently struck.Instructions are provided for the proper preparation of the lens and cartridge.During use, it states to ensure that the cartridge tip is not damaged during the advance of the cartridge into its final position in the handpiece.The dfu adequately provides instructions and precautions for the proper use and handling of the cartridges and intraocular lens use.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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 5088634
• MDR Text Key: 26230880
• Report Number: 2648035-2015-00830
• 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: Physician
• Type of Report: Followup
• Report Date: 01/05/2016

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: Health Professional
• Device Expiration Date: 04/17/2016
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CA02507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• 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