MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown not provided, (b)(6) 2017 implant date is being provided as the best estimate as the lens was explanted one week later.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model z9002, +23.5 diopter) was explanted from the right eye of a (b)(6) female patient because of residual refractive errors.No incision enlargement, no complications, no injury and no additional procedures were required.Another lens, same model higher diopter (+26.0) was implanted as a replacement.The patient was reported as recovered.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 10/11/2017.Device returned to manufacturer?: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed only half of lens with one haptic was returned.Loose fibers/particles were observed on lens piece related the handling of the unit out of a sterile environment.Residue of lubricant material was also observed on lens piece.No damaged was observed to the haptic.The conditions of the lens returned is consistent with a unit that has been previously handled and prepared for surgical process.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on the complaints revealed no additional investigation requests 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 abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6912513
• Report Number: 2648035-2017-01789
• Device Sequence Number: 99162
• Product Code: HQL
• UDI-Device Identifier: 05050474530768
• UDI-Public: (01)05050474530768(17)220224
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/24/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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
• Patient Age: 38 YR