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

Model Number PCB00

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Hyphema (1911)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that technician was preparing the intraocular lens, (iol), model pcb00.The first injector used wasn't working properly so the doctor asked to use a new injector.The doctor reported that the screw in wasn't working properly but he continued to engage the plunger.The lens was forcefully ejected out of the cartridge and hit the iris causing hyphema.The bleeding was controlled by the doctor and the lens was centered.The next day the patient seemed okay with no active bleeding.No further information was provided.

Manufacturer Narrative

(b)(4): if explanted, give date: na (not applicable) to date, the intraocular lens remains implanted.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

The manufacturing record review was performed.All process operations presented in the manufacturing record review were in compliance with manufacturing specifications.No deviation or non-conformity related to the customer claim was generated.A review of process manufacturing procedures in change control system was done during the period when this production order was manufactured and does not show any change that could be related with the complaint type.The documentation shows that the production order was manufactured according to specifications.The product met manufacturing release criteria.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

(b)(4).Additional information provided by the doctor stated that the lens remains implanted.When the lens shot out of the injector, it (fortunately) remained anterior of the iris.After the bleeding was controlled, the doctor repositioned the intraocular lens (iol) into the capsular bag.The patient did remarkably well and there were no post operative complications.The patient's uncorrected vision after surgery was excellent.The cartridge of the pcb00 lens system was returned to the manufacturer for evaluation.Residues of what appeared to be viscoelastic were observed in the cartridge body, tip and loading zone.No manufacturing assembly error was identified in the preloaded device.Cartridge was observed in the correct position (fully engaged into lower body of the pcb00 device).Stress marks were visible at the cartridge neck and tip.Functional testing could not be performed since the preloaded unit is a single use product.There is no indication that the damages observed on the pcb00 unit are related to manufacturing process.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: 4879476
• MDR Text Key: 6060240
• Report Number: 2648035-2015-00407
• 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: 08/18/2015

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: 01/21/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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): Other