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

Model Number	ZA9003
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown/not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.Device evaluation: the product was not returned; therefore, the reported issue was not verified manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
According to the surgeon, the intraocular lens (iol) had a crease in its center when it unfolded.The surgeon loaded the iol and began to insert it into the eye.As the lens was unfolding inside the eye, he could see that it didn't look right under the microscope.It was stated that the iol had a crease in it and was not unfolding correctly.The iol was removed and replaced with a different one during the same procedure.The incision did not have to be enlarged.The patient was not injured.The patient is doing fine.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6333267
• Report Number: 2648035-2017-00303
• Device Sequence Number: 1016541
• Product Code: HQL
• UDI-Device Identifier: 05050474528925
• UDI-Public: (01)05050474528925(17)180801
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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): 02/15/2017

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: Physician
• Device Expiration Date: 08/01/2018
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/15/2017
• 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: EMERALDC30, LOT CB39363