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	Capsular Bag Tear (2639); Vitrectomy (2643)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The system was evaluated by a field service engineer.All modes of operation and calibrations were verified and no failures were detected.The unit complied with all factory settings.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported a capsular tear resulting in a vitrectomy surgical procedure.The surgery center indicated the chamber collapse and the lens was aspirated.The surgery center indicated the anterior chamber collapse occurred in phaco, but phaco finished without noticing posterior capsule breakage.It is unknown whether it broke at the time of anterior chamber collapse, or whether it had broken before it.After that surgeon noticed a broken bladder at the time of irrigation and aspiration segment, but sudden removal with bladder because the bladder was erroneously aspirated and the zonules were broken.A vitrectomy procedure was performed.The wound was expanded to about 2.8 mm to 4.0 mm and the iol was sutured to the ciliary body.This report is for the tubing pack.A separate report will be submitted for the phacofragmentation unit.
Additional Manufacturer Narrative
Device available for evaluation? yes returned to manufacturer on: 05/03/2018.Device returned to manufacturer? yes device evaluation: the opo71 tubing pack lot# 60087370 was returned within its original packaging.A visual inspection of the returned device did not reveal any damage to the cassette, tubing lines, or luer fittings, and all parts were assembled correctly.Prime, irrigation, and aspiration tests were performed and all results were within specification.The reported aspiration issue could not be confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the pi lot# 60087370.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• Common Device Name: PHACO TUBING
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7466848
• Report Number: 3006695864-2018-00941
• Device Sequence Number: 16542297
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)200926(10)60087370
• 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): 06/08/2018

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: 09/26/2020
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60087370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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: 68 YR