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

Model Number	ZCB00
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the side of the intraocular lens (iol) was dented.The issue was noticed when removing the iol from the packaging.There was no patient contact or involvement.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.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 additional investigational requests 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.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 4/24/2018.Device evaluation: the zcb00 lens was returned it its original package.Visual inspection using microscope magnification was performed: loose fibers/particles were observed on lens that may be related to the handling of the unit out of a sterile environment.Residues of lubricant material were also observed on the lens.Part of the len's edge was also slightly bend.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The reported complaint was verified.Based on the investigation result, there is no indication of product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.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: 6815822
• Report Number: 2648035-2017-01543
• Device Sequence Number: 19082399
• Product Code: HQL
• UDI-Device Identifier: 05050474531598
• UDI-Public: (01)05050474531598(17)200311
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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,Followup,Followup
• Report Date (Section B): 05/24/2018

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: 03/11/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 04/26/2018
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 01/08/2018; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1