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

Model Number PCB00V

Device Problems Break (1069); Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as the lens was not fully implanted, it was inserted and removed.If explanted, give date: not applicable, as the lens was not implanted; therefore, not explanted.(b)(6).(b)(4).This report is being filed on an international device; tecnis optiblue 1-piece iol, that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the united states under pma p980040.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the screw mechanism did not engage with no lock sound on a pcb00v.The doctor pushed and advanced the plunger and the iol was implanted with no trailing haptic.As a result, the doctor conducted removal and replacement with incision enlargement.The operation was delayed about 30 minutes.No other information was provided.

Manufacturer Narrative

Corrected data: on the initial report initial reporter¿s name is only entered as doctor as the physician¿s name was not provided.This was not noted to date the physician¿s name is still unknown/ not provided.Additional information: device available for evaluation ¿ yes, returned to manufacturer on 11/01/2016.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Device inspection was performed and the plunger component was observed in advanced position and the cartridge was correctly engaged into lower body of the pcb00v.The lens was cut in two pieces with no damages on the lens haptics.Therefore, the reported issue of haptic detached was not verified.The reported issue of preloaded plunger did not lock was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.A search on complaints revealed no other complaint was received from this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS OPTIBLUE 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: 6068593
• MDR Text Key: 58815194
• Report Number: 2648035-2016-01706
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561731
• UDI-Public: (01)05050474561731(17)180904
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 09/04/2018
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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