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

Model Number ZCB00

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/05/2015

Event Type  Injury  

Manufacturer Narrative

The intraocular lens was returned to the manufacturer for evaluation.The lens was received cut into two parts and were inspected at 10x microscope magnification.Visual inspection revealed that the lens pieces received had what appeared to be viscoelastic residue and surface residuals (fiber/particles).The lens condition is consistent with a lens that was removed from the patient¿s eye.The manufacturing record review was performed.All process operations were in compliance with manufacturing procedure specifications.The documentation showed that the production order was manufactured according to specifications.The product met manufacturing release criteria.All pertinent information available to abbott medical optics at the time of this report has been submitted.Placeholder.

Manufacturer Narrative

(b)(4).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 implant as the eye was unable to support the lens.They even tried using the stabilizer and it still did not work.The incision was enlarged to remove the lens and the stabilizer.A model z9002 lens was inserted and the patient was doing fine with no complications.

Manufacturer Narrative

Concomitant medical products: capsular tension ring, (stabilizer) model stbl13us, serial number: (b)(4).All pertinent information available to abbott medical optics has been submitted.Placeholder.

• Brand Name: TECNIS 1-PIECE
• 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: 4560790
• MDR Text Key: 13242744
• Report Number: 2648035-2015-00091
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/12/2018
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2015; 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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
• Treatment: CARTRIDGE MODEL 1MTEC30, LOT CP02409
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR