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

Model Number	ZLB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, exact date not provided (2017).If explanted, give date: not applicable, lens remains implanted.(b)(4).An attempt has been made to obtain missing information and has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 13.0 diopter intraocular lens (iol) was implanted in the patient's left eye on (b)(6) 2017 with no patient injury.Post-operatively, the patient ended up -1.75 diopters and an explant is planned on 2017 to replace the lens with the same model, but different diopter of 10.5.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported and confirmed that the replacement lens was a zlb00 10.5 diopter intraocular lens (iol) and the explant date was (b)(6) 2017.No additional information was provided.Update to required intervention.If explanted, give date: (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.Therefore, reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints search revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6854328
• Report Number: 9614546-2017-00862
• Device Sequence Number: 16421844
• Product Code: MFK
• UDI-Device Identifier: 05050474560536
• UDI-Public: (01)05050474560536(17)190312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/12/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/12/2017; 03/06/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/07/2017; 03/30/2018
• 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: Other; Required Intervention