MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Implant date: not applicable; the lens was not implanted.Explant date: not applicable; the lens was not implanted.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was initially reported that the preloaded system (pcb00) would not insert properly.In follow-up, it was reported that the haptic was sticking to optic while inserting.Reportedly, there was patient contact, but no change of procedure, no delay, or adverse effects to the patient.The lens was not implanted/partially implanted.

Manufacturer Narrative

Device evaluation: the intraocular lens was returned to the manufacturer for evaluation.There was viscoelastic residue on the cartridge consistent with the device handling.The push rod did not slide through the cartridge as expected, the lens adhered to the walls, and thus no lens delivery was possible.Reported haptic stuck to optic was not verified.The manufacturing record and related documents show that the production order was manufactured according to specifications.There are no related non-conformity reports found in the manufacturing record review for this complaint.A review of the global quality management system did identify any field actions.The directions for use (dfu) was reviewed which adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results, reported complaint was not confirmed.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• 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; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5195176
• MDR Text Key: 30461897
• Report Number: 2648035-2015-01088
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• 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: 02/15/2016

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: Occupational Therapist
• Device Expiration Date: 05/29/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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