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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported a posterior capsule tear had occurred.No further information was provided.
Additional Manufacturer Narrative
Additional information: information was received confirming that the capsule tear occurred when the lens was being inserted into the eye.The physician noticed that there was capsule tear in the posterior area.However, they were unsure if the tear was attributed to patient anatomy or to a product quality issue.The customer was able to confirm that there was no patient post-op injury, no incision enlargement and no vitrectomy required.No other information was provided.Device available for evaluation ¿ yes, returned to manufacturer on 12/08/2016.Device returned to manufacturer ¿ yes.Device evaluation the intraocular lens (iol) was returned to the manufacturer.Fibers/particles were observed on lens related to the handling the lens.Residue of viscoelastic solution were also observed which indicates that the unit was handled and prepared for surgical use.No product damaged was observed on the lens.The reported event issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.There were no non conformances related to this complaint.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Corrected data: additional information was received with the returned product.This information was inadvertently not filed with investigation results on the previous mdr follow-up report.The information received confirmed that the issue involved a female patient's right eye and the event occurred on (b)(6) 2016.(b)(6).Gender/sex: female.Date of event: (b)(6) 2016.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: 6081526
• Report Number: 2648035-2016-01756
• Device Sequence Number: 13853735
• Product Code: HQL
• UDI-Device Identifier: 05050474548749
• UDI-Public: (01)05050474548749(17)190519
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 02/02/2016

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: 05/19/2019
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 01/11/2017; 02/02/2017
• 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: Other
• Patient Age: 78 YR