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

Model Number	AAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that haptics tore off due to handling problems with the intraocular lens (iol).The broken iol was removed and replaced with a new one.Patient involvement and user injury were reported.A 5 minute delay in the procedure was also reported.No vitrectomy was performed.Enlargement of the incision from 2.4mm to 2.9mm occurred.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the explanted intraocular lens was discarded by the customer.Therefore, the complaint issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6255250
• Report Number: 2648035-2017-00116
• Device Sequence Number: 426907
• Product Code: HQL
• UDI-Device Identifier: 05050474548633
• UDI-Public: (01)05050474548633(17)200329
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

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: 03/29/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/09/2017
• 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