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

Model Number Z9002

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a z9002 22.5 diopter intraocular lens (iol) was inserted and then removed as the lens could not be centered.The lens was replaced with an anterior chamber lens.Incision enlargement was required to accommodate the anterior chamber lens, but no vitrectomy required.There was no patient post-op injury reported.

Manufacturer Narrative

Additional information: age or date of birth: (b)(6) this information was provided with the returned device.Device available for evaluation ¿ yes, returned to manufacturer on 02/13/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and small particles that could be related to handling the unit out of a controlled environment were observed on the surface of the iol.Residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) were detected in the iol , indicating the device was handled and prepared for surgical use.The lens was observed with good shape haptics without defects in optic zone.Based on the evidence observed, the reported device problem code ¿other (lens would not center)¿ could not be verified in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigation request received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS CL
• 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: 6255079
• MDR Text Key: 64886973
• Report Number: 2648035-2017-00115
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530744
• UDI-Public: (01)05050474530744(17)210308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/08/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR