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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICSZ9002TECNIS CL

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ABBOTT MEDICAL OPTICS Z9002 TECNIS CL   Back to Search Results
Model Number Z9002
Device Problems Explanted; Lens replacement
Event Date 04/25/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the patient developed endophthalmitis postoperative cataract surgery and intraocular lens implant. The inflammation was treated without success by washing the eye. The iol was removed and replaced with a different model. Patient's condition is stable.

 
Manufacturer Narrative

The lens was not received by the manufacturer for analysis. The relationship between the device and the adverse event is inconclusive, however we do not believe it is manufacturing related. Iol met all manufacturing specifications prior to release. Iol not returned.

 
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Brand NameZ9002
Type of DeviceTECNIS CL
Manufacturer (Section F)
ABBOTT MEDICAL OPTICS
1700 e. st. andrew place
santa ana CA 92705 4933
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
1700 e. st. andrew place
santa ana CA 92705 4933
Manufacturer (Section G)
AMO PUERTO RICO
road 402n
p.o. box 1408
anasco PR 00610
Manufacturer Contact
grace kropidlowski
1700 e. st. andrew place
p.o. box 25162
santa ana , CA 92799-5162
(714) 247 -8200 ext 8599
Device Event Key1460993
MDR Report Key1398191
Event Key1334284
Report Number2648035-2009-00070
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/11/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device EXPIRATION Date09/30/2013
Device MODEL NumberZ9002
Device Catalogue NumberZ9002
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age6 yr
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/11/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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