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 Vitrectomy (2643)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that customer experienced issues with a model pcb00 intraocular lens.The injector was stuck but was injected into the (eye) chamber, this resulted in a chamber hole and a new/second lens was used.No secondary intervention required and no delay was reported.No further information was provided.

Manufacturer Narrative

Date of event: (b)(6) 2016.Device available for evaluation: yes.Returned to manufacturer on: 11/09/2016.Returned to manufacturer: yes.Device evaluation: the intraocular lens was returned to the manufacturing site for investigation.The cartridge component was observed correctly engaged into lower body of the pcb00 device/delivery system.The plunger component was observed in the advanced position.The plunger was gently pulled back and found properly locked.No damage was observed on the plunger push rod assembly.Visual inspection at 10x microscope magnification was performed.The lens was not in the insertion device/delivery system.Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the lens thru the cartridge.The cartridge was observed cracked.Viscoelastic residue was observed at the cartridge tube/tip.The cartridge crack observed could be related to the handling process and as a consequence of product use.The customer's reported plunger rod issue could not be verified.Manufacturing record review: a review of the manufacturing records was performed.The manufacturing production order was evaluated and the devices were manufactured within specifications.The units were released according to specification.The visual inspection specifications for defects are defined to release lenses within specifications and in compliance with the product intended use.The review did not identify any non-conformance reports (ncr) and/or exception reports (er) that were related to the reported event.A search on complaints revealed no other complaints for this production order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.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, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6068246
• MDR Text Key: 58814283
• Report Number: 2648035-2016-01690
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)180612
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/12/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR