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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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: unknown/not provided.If explanted; give date: unknown/not provided.Device evaluation: the complaint unit was received for evaluation.Visual inspection using microscope magnification was performed.The lens was observed cut.Only one half of the lens including a haptic was returned.Also, another haptic was observed broken and adhered to the optic section of the lens confirming the reported issue.Residue of viscoelastic (ovd) were detected in the lens piece returned.The condition of the lens and the way in which the cut is formed is consistent with a lens that has been cut as part of the surgical process.The reported issue was confirmed on the return.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 provide the customer with proper usage instructions and guidelines.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.Attempt has been made to obtain missing information; however, to date, no response has been received.
Event or Problem Description
It was reported that the intraocular lens (iol) had a broken haptic.No additional information has been provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information: in the initial mdr submitted, the device evaluation stated that the product was broken.Further investigation found that the haptic was in fact detached.The following section has been updated accordingly.No additional information was provided.The complaint unit was received for evaluation.Visual inspection using microscope magnification was performed.The lens was observed cut.Only one half of the lens including a haptic was returned.Also, another haptic was observed detached.Residue of viscoelastic (ovd) was detected in the piece of lens returned.The condition of the lens and the way in which the cut is formed is consistent with a lens that has been cut as part of the surgical process.The reported issue was not confirmed on the return.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information: during a follow up, the customer stated that there was no patient involvement.(b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6822736
• Report Number: 2648035-2017-01553
• Device Sequence Number: 13463080
• Product Code: HQL
• UDI-Device Identifier: 05050474531567
• UDI-Public: (01)05050474531567(17)190728
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2017

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: 07/28/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 09/14/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/15/2017; 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1