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

Model Number PCB00

Device Problem Premature Activation (1484)

Patient Problem No Code Available (3191)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age at time of event or date of birth: unknown; sex/gender: unknown; explant date: not applicable; lens remains implanted at the time of submitting the mdr.(b)(6).Section has been completed by the manufacturer.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the pre-implantation procedure on a preloaded system (pcb00) was done accordingly by the assistant nurse.In implantation the lens was advanced by rotating the rod.Suddenly, the lens stopped moving forward but after some turns of the rod, the lens quickly advanced into the patient's eye and at the same time it scratched the iris.Minor defect with bleeding in the iris was noticed.Bleeding stopped quickly with ovd (ophthalmic viscoelastic device) compress.Patient checked twice post-operatively in the first day and approximately three weeks after operation.No defects or other problems were found.Patient is followed by own practitioner and will contact operating hospital if necessary.About one to two minutes delay in the procedure.No defects were found in post-operative checks.

Manufacturer Narrative

The preloaded insertion system was returned to the manufacturer for evaluation.The return sample was visually inspected under a microscope.Scarce ovd (ophthalmic viscoelastic) residues were observed inside the cartridge.The plunger was observed loaded until the black hatch mark as is required as ready position.The cartridge was observed in the correct position (fully engaged into lower body of the pcb00 device).Although, the customer initially reported that the lens was implanted, the pcb00 device was observed that the pushrod was completely out.Therefore, the reported complaint could not be verified.A review of the directions for use (dfu) was conducted.The dfu adequately provides instructions for the proper use and handling of the device.The manufacturing record review was performed.The lenses were manufactured within specifications.The units were released according to specification.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: 5195022
• MDR Text Key: 30065779
• Report Number: 2648035-2015-01085
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 12/29/2015

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: Health Professional
• Device Expiration Date: 05/20/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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