MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SMARTLOAD VITAN HANDPIECE; INTRAOCULAR, LENS, GUIDE

Model Number	DK9000
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Inaccurate Delivery (2339); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: not applicable, there is no indication the lens was implanted.If explanted, give date: not applicable, there is no indication the lens was implanted, therefore, not explanted.Telephone number: (b)(6).The intraocular lens (iol) has not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Because it is not known which missing haptic issue was experienced with which serial number lens, (b)(4), has been applied to both reports.A separate report is being filed for each device.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that there were two smart load intraocular lenses that could not be implanted as they both were stuck.Possibly the cartridge(s) were defective, and one lens had a missing haptic (haptic was not there).The two devices were reported at the same time for the same patient.Through follow up it was confirmed the injector (customer is referring to the cartridge), got stuck and the lenses could not be implanted.Because of the lenses being stuck, one lens had a missing haptic and was taken out (not fully delivered, due to being stuck).It is unknown which of the two identified lenses had the missing haptic issue.This report captures the event for one of the two reported lenses.A separate report is being submitted for the other reported lens.No further information is available.
Additional Manufacturer Narrative
Additional information: initially the event was reported against the preloaded smartload lens, however in follow-up the customer confirmed the issue was not the smartload lens, but the dk9000 injector handpiece which was faulty.Therefore, reporting is captured under the smartload lens product records.Section d1: brand name: smartload vitan handpiece section d2: common device name: intraocular, lens, guide section d2: device product code: corrected data: section d4 model number: dk9000 catalog number: dk9000 lot number: 0016 section d4: expiration date: not applicable.Unique identifier (udi) number: (b)(4).Section h4: device manufacture date: mar.23, 2021 all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 16 may 2022 section h3.Device evaluated by manufacturer? yes device evaluation: the dk9000 unfolder was received within a sterilization pouch.The plunger rod was observed to be bent.How and when this damage was introduced cannot be determined.The material of the pushrod is titanium, which would need to be subjected to an impact or force that would result in damage to the pushrod tip.As such, the pushrod would have had to be subjected to the damage (bending of the pushrod tip) by some other action outside of normal lens delivery.There is no further information provided to indicate when this damage may have occurred.Potential root causes can include the device being dropped or damaged during handling, resterilization, etc.Product deficiency and product malfunction cannot be confirmed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD VITAN HANDPIECE
• Common Device Name: INTRAOCULAR, LENS, GUIDE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13809107
• Report Number: 3012236936-2022-00638
• Device Sequence Number: 2085785
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0016
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2024
• Device Model Number: DK9000
• Device Catalogue Number: DK9000
• Device Lot Number: 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 06/01/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/19/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown