MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that the intraocular lens (iol) would not advance as it was stuck in the cartridge.The haptic tore.The event happened during handling but prior to insertion.It was reported that ¿there was patient contact by touching the eye but not inserted¿.During follow up, it was learned that there was patient contact with the iol, the iol was fully inserted, the patient was left aphakic, there was no vitrectomy, and there was no incision enlargement or suture required.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 05/16/2017.Device returned to manufacturer? yes.Device evaluation: the product was returned for evaluation.Visual inspection with the unaided eye shows the product is damaged and incomplete, most probably to make removal and replacement possible.Considering the condition of the lens, additional analysis was not possible.The reported complaint 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 similar 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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6568078
• Report Number: 9614546-2017-00423
• Device Sequence Number: 13715555
• Product Code: MFK
• UDI-Device Identifier: 05050474535565
• UDI-Public: (01)05050474535565(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention