MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SIGNATURE PACK, DISPOSABLE TUBING; PHACO TUBING

Model Number	OPO71
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(toxic anterior segment syndrome).Device evaluation: a review of the records related to the device that included labeling, manual, trending, and risk documentation were performed.Based on the manufacturing records review, the production order was manufactured according specifications.No issues were identified after completing a process review of our manufacturing and sterilization records.The products were released within specification when this lot was completed and sterilized.The directions for use instructions and precautions sections provide the customer with information on properly handling the device.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after the cataract procedure using opo71 patient presented with tass (toxic anterior segment syndrome) and edema and medical intervention was required.
Additional Manufacturer Narrative
It was inadvertently not included in the initial report the following sentence: the descemet's membrane edema was resolved by prescribing steroid eye drops.

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• Common Device Name: PHACO TUBING
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6806633
• Report Number: 2648035-2017-01521
• Device Sequence Number: 121877
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)200127(10)CC01101
• Combination Product (Y/N): N
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: Health Professional
• Device Expiration Date: 01/27/2020
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: CC01101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/20/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 78 YR