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

Model Number UNKNOWN

Device Problems Bent (1059); Difficult or Delayed Positioning (1157); Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

The product is not implantable.The lot number was not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an unknown cartridge model cracked down the center lengthwise from the bottom of the cartridge to the tip during handling and prior to insertion.In addition, the za9003 23.5 diopter intraocular lens (iol) became stuck in the cartridge, which caused a haptic to crimp.There was no patient contact.No additional information was provided.

Manufacturer Narrative

Conclusion code updated (b)(4) as previously provided.The surgery center discarded the device.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing control was not reviewed since no cartridge model was reported.Labeling review: the labeling review was not completed since no cartridge model was reported.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: UNKNOWN
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• 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: 7182184
• MDR Text Key: 96967754
• Report Number: 2648035-2017-02392
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• 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
• Treatment: ZA9003 23.5 DIOPTER IOL, S/N (B)(4)