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

Model Number	ZCB00
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable no patient involvement reported.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was noticed scratched or dirty when opened from the sterile package.Reportedly, another lens was used for the surgery.No patient involvement or injury was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 03/15/2018.Device returned to manufacturer? yes.Device evaluation:the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection under the microscope showed some particles on the lens.No scratches were observed.The particles were analysed using the fourier transform infrared (ftir) spectroscopy.The results revealed that one piece of debris was consistent with a mixture of some or all of the following: water/moisture, surfactant/emulsifier, polycarboxylate; which suggested the presence of a detergent or a cleaning agent.Another piece of debris was consistent with a mixture of protein and fatty acid ester.Potential and indirect exposure to this type of material is possible.The customer's reported complaint for dirt on the lens was verified; however since the lens was handled it was not possible to confirm if the particles or substances observed are related to manufacturing process.In the manufacturing processes there are various cleaning operations and 100% visual inspection utilizing a microscope that would have identified, measure and discarded a lens with a similar particulate.A product quality deficiency was not identified.Manufacturing records review:the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 7114154
• Report Number: 2648035-2017-02260
• Device Sequence Number: 13761754
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)210425
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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: 04/25/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1