MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number	1MTEC30
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the lens would not fully come out of the cartridge and was partially delivered into the left eye due to possible loading error.Another lens was used.There was no need for incision enlargement, vitrectomy, or sutures.There was no patient injury.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
It was discovered that the event of partially delivers was reported against the lens.For a complaint of partially delivers and stuck in cartridge, the report should be against the cartridge with the lens as a concomitant product.A correction mdr is required.The following fields have been updated: brand name: platinum 1 series.Product code#: kyb.Common device name: surgical adjuncts.Model#: 1mtec30.Catalog#: 1mtec30.Lot#: cd00737.Expiration date: 1/18/2019 udi #: (b)(4).Concomitant medical products: zcb00, serial #: (b)(4).Manufacturing site address: road 402 north, km 4.2, anasco industrial park, pob 14, anasco, pr, us.00610.Pma/510(k) #: k081545.Device manufacture date: 1/18/2018.Device evaluation: since product is not available, the reported complaint issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.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: PLATINUM 1 SERIES
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7455063
• Report Number: 3011852734-2018-00060
• Device Sequence Number: 1550862
• Product Code: KYB
• UDI-Device Identifier: 05050474531642
• UDI-Public: (01)05050474531642(17)210929
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K081545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/18/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD00737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZCB00, SERIAL #: (B)(4)