MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC SOLO IA TIP, STRAIGHT, .3MM; PHACO ACCESSORY

Model Number	OPO1A20STR
Medical Device Problem Codes	Material Erosion (1214); Flaked (1246); Restricted Flow rate (1248)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device evaluation: the actual device was not returned.A photo of model opo1a20str, lot no 085976 was provided and evaluated by the manufacturer.From the photo, there appears to be numerous scratches and gouges on distal end of the aspiration cannula.This unit would not have shipped in this condition and would have been rejected per final inspection.The amount if scratches on the tip suggests it has made repeated contact with another metallic object, either during surgery or reprocessing such as contacted with another ophthalmic instrument).Besides the suspected product show surgical residue in the aspiration port, which demonstrates that it was not reprocessed adequately.A capsular tear may have occurred if tissue was contacted by damaged surface.The aspiration port of this solo handpiece is not designed or intended to make direct contact with the capsular bag.The evidence implies that the capsular tears were either caused by the unit being used incorrectly and /or after it became damaged.The device should not have been used in this condition (against direction for use indication) the probable cause will be filed as customer use issue and customer maintenance issue since the unit was used after being damaged by improper handling and reprocessing.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the tip model opo1a20str, lot no 085976.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.
Event or Problem Description
During a cataract procedure, a broken posterior capsule occurred on the operative eye resulting in a vitrectomy procedure.A description from the surgery center indicated during the irrigation and aspiration portion, there was resistance that was caught at the phaco tip.It was observed that the gold color surface of the tip seemed to be stripping away.The broken capsule resulted in a vitrectomy procedure and the anterior vitreous zone was resected.No additional information was provided.This is 3 of 4 reports.
Additional Manufacturer Narrative
In initial report, the lot number 085976 was inadvertently selected as it should have indicated lot no.085876, therefore this follow up in section has the correct lot number listed.In initial report, in section the lot number 085976 was inadvertently listed as it should have indicated lot no.085876.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: SOLO IA TIP, STRAIGHT, .3MM
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7939680
• Report Number: 3006695864-2018-01982
• Device Sequence Number: 1914192
• Product Code: HQC
• UDI-Device Identifier: 05050474521070
• UDI-Public: (01)05050474521070(17)991231(10)085876
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

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 Model Number: OPO1A20STR
• Device Catalogue Number: OPOIA20STR
• Device Lot Number: 085876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 10/25/2020
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/22/2018; 11/03/2020
• 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
• Date Report Sent to FDA: 01/01/2005