FDA Adverse Event Malfunction Summary report: N

TECNIS CL

MDR report key: 6630192 · Received June 9, 2017

Report

Report Number: 2648035-2017-01034
Event Type: Malfunction
Date Received: June 9, 2017
Report Date: August 25, 2017
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQL
UDI-DI: 05050474530737
PMA / PMN Number: P880081
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE. ONLY AN EMPTY BOX WAS RECEIVED; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

CORRECTED DATA: IN THE INITIAL MDR, AN INCORRECT PMA/510(K) CODE WAS ENTERED. THE CORRECT CODE IS P880081. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A HOLE IN AN INTRAOCULAR LENS. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
412392	TECNIS CL	MONOFOCAL IOLS	HQL	ABBOTT MEDICAL OPTICS	Z9002		05050474530737

Patients

Seq	Age	Sex	Outcome	Treatment
1