MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that white spots were observed on a zcb00 14.5 diopter intraocular lens (iol) during handling and prior to insertion.There was no patient contact.Another lens was used to complete the surgery.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 04/12/2018.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection showed the lens was placed inside the wheel case insert and in an open inner pouch.No damaged/defect was observed on the lens.The lens was in good conditions.Something like white spot was observed on the lens surface.The reported issue was verified.The condition of the sample returned is consistent with a product that was previously handled and it could not be determined if the reported issue is related to the manufacturing process.Based in the analysis there is no indications of product quality deficiency.Based in the eag lab.Analysis results and the subject matter expert (sme) evaluation the ftir (fourier transform infrared spectrometer) analysis indicates that the white spot foreign material is consistent with a protein structure (i.E.Natural fibers class).This includes hair/fur or wool, skin flakes, which can be procedure by operators during manufacturing process.Based on visual confirmation, the white particle is more aligned towards a skin particle.The manufacturing controls should be capable to identify the presence of this type of particulate or substance during the inspection controls defined as part of the manufacturing process.In addition, as required in the direction for use (dfu) the lens should be removed from the pouch in a sterile environment, and examined thoroughly to ensure particles have not been attached before implanting.Based on the evaluation observed this material is common on material used by protecting clothing of production operation.Therefore, it cannot be fully confirmed it was identified from manufacturing process, as the reported lens was opened.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, 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-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7424150
• Report Number: 2648035-2018-00499
• Device Sequence Number: 144770
• Product Code: HQL
• UDI-Device Identifier: 05050474531604
• UDI-Public: (01)05050474531604(17)210517
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 05/14/2018

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: 05/17/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1