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

Model Number PCB00

Device Problem Premature Activation (1484)

Patient Problems Hyphema (1911); Vitreous Loss (2142); Blood Loss (2597)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

Explant date: if explanted; give date: n/a (not applicable).No indication of lens explant.Initial reporter phone: (b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that, during insertion, the intraocular lens (iol) shot in the eye suddenly as the iol introducer was defective.This led to iris trauma and hyphema (bleeding in the eye).Blood and fluid loss were reported.Viscoelastic was used to stabilize the iol and stop bleeding, with careful positioning of the iol in the lens capsular bag.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Additional information was received and it was learnt that the lens remains implanted but it is possible that a secondary surgical procedure will take place.Patient outcome: bleeding and increased eye pressures.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 5/9/2017.Device returned to manufacturer? yes.Device evaluation: the complaint unit was received.The plunger was locked and fully advanced.There was no plunger, assembly and/or cartridge molding issue observed.There was no assembly issue with the plunger and/or plunger tip.Inspection at 10x microscope magnification was performed.A trace amount of viscoelastic inside the cartridge was observed.The pushrod tip was observed out of the cartridge tip without damages.No issues with the device were identified.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6470890
• MDR Text Key: 72056076
• Report Number: 2648035-2017-00650
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)191109
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/09/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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