MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a.The lens was removed and replaced during the same procedure.If explanted; give date: n/a.The lens was removed and replaced during the same procedure.Device evaluation: the intraocular lens (iol) was retuned to the manufacturing site for investigation.Visual inspection at 10x microscope magnification was performed.The lens was observed ripped/torn with a cut at the lens edge (near the tip of the loop insertion).Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device) was detected on the lens body.The reported issue of iol torn was verified on the returned lens sample.Based on the evidence observed, the reported lens was handled and prepared for surgical use.Manufacturing record review: a review of the manufacturing record was performed.The manufacturing process was evaluated and the devices were manufactured within specifications.The units were released according to specifications.There were non non-conformances reports that were associated to this production order.A search of complaints revealed that no other investigation has been received that were associated to this production order.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation the reported complaint was confirmed and there was no indication of product deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
An intraocular lens (iol) tore during insertion into the eye.The iol was removed without difficulty and another lens of the same model and diopter was inserted.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5961189
• Report Number: 2648035-2016-01474
• Device Sequence Number: 569630
• Product Code: HQL
• UDI-Device Identifier: 05050474530645
• UDI-Public: (01)05050474530645(17)210317
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNFOLDER CARTRIDGE PSCST30, LOT CB34567