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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Some marks were observed on lens surface.Both haptics were observed detached.The detached haptics were not returned.The conditions of the product returned is consistent with a unit that has been previously handled and prepare for surgical process.The complaint issue reported as haptic damaged could not be verified.However, haptic detached was identified on product returned.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 investigations 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 abbott medical optics has been submitted.
Event or Problem Description
It was reported that a za9003 28.0 diopter intraocular lens (iol) was explanted due to a broken haptic.No additional information was provided.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6878089
• Report Number: 2648035-2017-01677
• Device Sequence Number: 19142161
• Product Code: HQL
• UDI-Device Identifier: 05050474529175
• UDI-Public: (01)05050474529175(17)201221
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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: 12/21/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/19/2017
• 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