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

Model Number PCB00

Device Problems Difficult to Insert (1316); Device Slipped (1584); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

Udi #: (b)(4).Pt age/date of birth: unknown.Pt gender/sex: unknown.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the patient had an uncomplicated operation until the intraocular lens (iol) model pcb00 insertion.The first cartridge was inserted and the push rod over rode the iol which failed to exit the cartridge completely.It was removed and the second cartridge was inserted.The screw mechanism slipped multiple times, failing to deliver the lens at all from the cartridge.No further pcb00 lenses were available, so a non amo was implanted which was placed after a total delay of about 15 minutes from the start of iol insertion.The patient has done well with 20/20 vision and near plano results with the non amo lens in both eyes.Further information indicated that the first lens attempted was partially inserted, the lens was about 2/3 way into the patient's eye.The doctor did not know which event occurred with which serial number, thus both lenses are being reported.A separate mdr is being provided for the second lens reported.

Manufacturer Narrative

The manufacturing records for the intraocular lens (iol) were reviewed.The manufacturing process record was verified and found that the lens was manufactured within specifications.There were no associated deviation or non-conformity reports related to reported complaint.The lens was released according to specification in compliance with the product intended use as required.The device manufacturing procedures were performed as required.Directions for use (dfu) instructions include how to prepare and use the insertion system along with time recommendations.Using the system to fully advance the lens appropriately with use of the plunger and locking mechanisms.Discard the device if the lens has been fully advanced in the delivery system for more than 1 minute.For delivery, slowly advance the lens until the lens is fully released from the insertion system tip.Precautions include to not advance the lens unless ready for lens implantation.The recommended temperature for implanting the lens is at least 17°c.The combination of low operating room temperatures and high iol diopter powers may require slower delivery.The use of viscoelastics is required and the use of balanced salt solution alone is not recommended.Based on the manufacturing record review, no deviation or assignable cause was identified when this production order was completed.The documentation showed that the production order was manufactured according to specifications.The lens met specification prior to release.The intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection was conducted and the plunger was observed in a fully advanced position.Cartridge was observed fully engaged into lower body of the device.The lens was observed stuck in the cartridge tube.The push rod tip overrode the lens in cartridge.Based on the investigation, no defects inside the cartridge tube were observed that could lead to the iol getting stuck in the cartridge during surgery.No defects in the plunger/push rod tip was identified that could impair functionality in the lens and delivery system.The iol was able to advance from the preloaded lens housing to the cartridge tube and then was stuck.The complaint could be related to advancing the plunger/push rod too fast and/or excessive pressure applied.The plunger component was observed engaged on the fully advanced position at the indicator black line as device directions require.Based on the evidence observed, the preload delivery system was not affected by the manufacturing process.The investigation results reasonably suggest that the probable cause could be related to an error in use.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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 5043469
• MDR Text Key: 25294274
• Report Number: 2648035-2015-00710
• 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: Physician
• Report Date: 10/08/2015

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: Physician
• Device Expiration Date: 04/03/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2015
• 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