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

Model Number PCB00

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/19/2015

Event Type  Injury  

Event Description

In follow up, it was learned that an incision enlargement was not performed.

Manufacturer Narrative

Date of this report: (b)(6) 2015.In follow up, it was learned that an incision enlargement was not performed as stated in the initial mdr.(b)(4).Device available for evaluation: yes.Returned to manufacturer on: 06/17/2015.A review of the manufacturing records was performed.All tests results showed a pass disposition.No deviation or non-conformance (ncr) related to the reported complaint was generated during the manufacturing process.The line clearance for all operations in the production order was evaluated and did not show any deviation due to plunger problems when this production order was completed.A review of the raw material/manufacturing procedures in change control system was done and did not show any change in manufacturing method, inspections or specifications that were related to the reported complaint.The lens met all specifications prior to release.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Event Description

It was reported that the intraocular lens (iol) was removed during the initial procedure.During the final stages of inserting the intraocular lens that was about three quarters of the way out of the tip of the injector, the trailing haptic was severed.The haptic damage was seen when the doctor started to turn the knob counter clockwise as if to retract the push rod.There was an incision enlargement; however, no vitrectomy was performed.The event was reported as a use error.There was no patient injury reported and the patient is doing fine.No further information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

Udi #: (b)(4).The intraocular lens (iol) was returned to manufacturing site for evaluation.Viscoelastic residues were observed at the cartridge neck and tip area.The detached haptic was observed located at the cartridge tip.Stress marks were detected at the tip area.Portions of the lens were stuck at the cartridge tip.Most of the lens was found out of the insertion device.The preloaded unit was correctly assembled.Cartridge was observed in the correct position; fully engaged into lower body of the pcb00 device.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Corrected data: correction date of event - through follow up it was confirmed that the date of event was actually (b)(6) 2015 and not (b)(6) 2015 as initially reported.This corrected data was known at the time of follow-up report #1 however was inadvertently not included.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: 4848845
• MDR Text Key: 19819350
• Report Number: 2648035-2015-00364
• 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 Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• 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