MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SOLO IA TIP, STRAIGHT, .3MM; PHACO ACCESSORY

Model Number	OPO1A20STR
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device manufacturer year 2017 the phacoemulsification machine was examined and tested at the customer location by an amo field service specialist (fss).The fss found no issues with the operation of the equipment.The fss performed a field service checklist.The system was verified for all modes of operations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
During a cataract extraction procedure, a hospital reported the posterior chamber ruptured during the irrigation and aspiration segment.The hospital indicated the intraocular lens (iol) was implanted in the capsular bag as there was no vitreous that came out.The patient was discharged from the hospital without any problems.The hospital requested to check and adjust the vacuum pressure and check the condition of the tip of i/a.This report is for the irrigation/aspiration (i/a tip).A separate report will be submitted for the phacofragmentation unit.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.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: SOLO IA TIP, STRAIGHT, .3MM
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7111168
• Report Number: 3006695864-2017-01317
• Device Sequence Number: 16371840
• Product Code: HQC
• UDI-Device Identifier: 05050474521070
• UDI-Public: (01)05050474521070(17)991231(10)081555
• 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): 04/14/2018

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?: Yes
• Operator of Device: Physician
• Device Model Number: OPO1A20STR
• Device Lot Number: 081555
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 04/14/2018
• 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: Other
• Patient Age: 83 YR