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

Model Number PCB00

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult To Position (1467); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Manufacturer Narrative

A manufacturing record review was performed.All process operations presented in the manufacturing record were in compliance with manufacturing instructions and specifications.All tests results showed a pass condition.No deviation or non-conformance report (ncr) was generated when this production order was manufactured.Device met manufacturing release criteria.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Event Description

It was reported that during implantation of the intraocular lens (iol), the haptics were not folded correctly and the haptics stuck to each other.There was no patient injury or impairment reported.The lens was successfully implanted.No further information was provided.

Manufacturer Narrative

Pt age/date of birth: unknown.Pt gender/sex: unknown.Explant date: if explanted, give date: na (not applicable) the lens remains implanted.Initial reporter: telephone number: (b)(6).All pertinent information available to abbott medical optics has been submitted.Placeholder.

• 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: 4704615
• MDR Text Key: 16784440
• Report Number: 2648035-2015-00238
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/26/2017
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2014
• 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