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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as the lens was inserted and removed.If explanted, give date: not applicable, as the lens was inserted and removed.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the haptic of a z9002 23.5 diopter intraocular lens (iol) broke off when inserting into the patient's operative eye.Reportedly, the lens was removed and an incision enlargement and vitrectomy were performed.No additional 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 loose fibers/particles on lens related to the handling of the unit out of a sterile environment.Residue of lubricant material was also observed on the lens.Also, one of the haptics was observed detached.The detached haptic piece was not returned.No damaged was observed to the other haptic.The conditions of the lens returned is consistent with a unit that has been previously handled and prepare for surgical process.The complaint issue reported as haptic detached was 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 complaints 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 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 was 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 92705
• MDR Report Key: 6933322
• Report Number: 2648035-2017-01844
• Device Sequence Number: 1089807
• Product Code: HQL
• UDI-Device Identifier: 05050474530768
• UDI-Public: (01)05050474530768(17)220223
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/23/2022
• 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: 09/14/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/09/2017
• 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