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

Model Number 1MTEC30

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

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.If implanted; give date: n/a (not applicable).The cartridge in not an implantable device.If explanted; give date: n/a (not applicable).The cartridge in not an implantable device.Phone: unknown/ not provided.Address, city, state: unknown/ not provided.Postal code: unknown/ not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported by the customer that the intraocular lens (iol) was observed with an optic broken during insertion into the anterior chamber.During follow up, it was learned that the iol actually got stuck in the cartridge.The iol was in contact with the eye.The doctor started to introduce the iol into the eye when it got stuck.There was no incision enlargement.There was no patient injury.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.The customer's reported complaint cannot be confirmed.Manufacturing record review: a manufacturing record review could not be performed as no serial 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.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7558304
• MDR Text Key: 109748145
• Report Number: 2648035-2018-00807
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• 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: 06/20/2018
• 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