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

Model Number 1MTEC30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Mark on lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a mark on lens optic edge.The lens is not available for investigation, as it remains implanted.There was no patient injury reported.No additional information provided.

Manufacturer Narrative

Device evaluation: the lens remains implanted, which it is not available for evaluation.However, two photos were attached in the complaint folder (cf).The photos were analyzed and appeared to be a scratch in the optic.Based on the photos, the reported complain was confirmed, but a product deficiency could not be determined.Manufacturing record review: a manufacturing record review could not be performed as no lot number was provided.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data/additional info: the initial report 2648035-2018-00458 was inadvertently submitted against the intraocular lens; however, it should have been filed against the cartridge as the customer suspects the cartridge caused damage to the lens.Brand name: platinum 1 series.Product code: kyb - surgical adjuncts, model #: 1mtec30, lot #: unknown/not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.Device available for evaluation; returned to manufacturer on: 06/06/2018.Pma/510(k) #: k081545.Manufacturing date: unknown/not provided as lot number was not provided.Device evaluation: the returned sample was received in a plastic bag.Visual inspection under the microscope showed lubricant material residue on the cartridge tube.Also stress marks were observed on the cartridge tube, which are typically caused and/or may well appear by the pass of the intraocular lens (iol) through the cartridge.There was no damage/defect observed on the cartridge that can cause damage to the lens.The reported issue was not verified.Based on the analysis there is no indication of a product quality deficiency.Manufacturing record review: the manufacturing record could not be reviewed since the lot number is unknown.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.

Manufacturer Narrative

Per follow up, the issue is believed to have been caused by the cartridge and/or the inserter.The doctor hasn't heard anything from patients regarding vision issues.Fields have been updated as follows: concomitant medical products: unfolder platinum series 064 d&k (lot is unknown), unfolder platinum series 063 d&k(lot is unknown).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 1408; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7398189
• MDR Text Key: 104428795
• Report Number: 2648035-2018-00458
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)
• Combination Product (y/n): Y
• Reporter Country Code: SE
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1