MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problems Break (1069); Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during the implantation of an intraocular lens (iol) the doctor was having difficulties as the lens was not sitting right in the patient's eye.Reportedly, in the attempt to fix the issue, the lens haptic broke/got damaged.The incision had to be enlarged in order to remove the iol, and sutures were used.Another lens was implanted as a replacement.No patient injury post-op was reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 07/27/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was received with viscoelastic residue.Both haptics were observed detached but only one haptic was returned.The returned haptic was observed bent and smashed.The lens optic was observed scratched and broken next to one of the drill holes.The customer's reported complaint was verified, however due to the condition of the lens returned and as initially reported by the customer, the lens haptic broke/got damaged during the initial procedure and related to the handling process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• 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: 6756235
• MDR Text Key: 81466220
• Report Number: 2648035-2017-01410
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)190503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/03/2019
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2014
• 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: CARTRIDGE EMERALDC30, LOT UNKNOWN
• Patient Outcome(s): Required Intervention