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

Model Number 1MTEC30

Device Problems Device Difficult to Setup or Prepare (1487); Split (2537)

Patient Problem Capsular Bag Tear (2639)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown, not provided.Sex/gender: unknown, not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Concomitant medical products: zcb00 lens, serial (b)(4); platinum injector, model and lot number unknown.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when the intraocular lens (iol) was deployed, it seemed to come out at an unusual angle and appeared to split the end of the cartridge.A capsular tear appeared from 4 to 9 o¿clock.The iol was left in position and inspected post-surgery.The account commented that there may have been difficulty loading.The event did not require unplanned medical or surgical intervention.There was no loss of 2 or more lines of best spectacle corrected visual acuity (bcva).There was no permanent visual impairment.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 5/1/2018.Device returned to manufacturer? yes.Device evaluation: the 1mtec30 cartridge was received in a bag inserted in a platinum handpiece.The handpiece push rod was observed advanced until the cartridge tip.The cartridge was removed and was observed under microscope; scarce amount of lubricant was observed through the cartridge.The cartridge tip was observed with stress marks and with small split in the cartridge tip.This condition could appear to be caused by the lens delivery.The complaint was verified however it could not be related to the manufacturing process.It could be related to the handling process due to the scarce amount of lubricant observed that could cause a tight lens delivered.Per direction for use (dfu) instructions, the entire inside of the cartridge should be filled with viscoelastic.No product quality deficiency was identified.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.Labeling review: the 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.

• 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: 7502600
• MDR Text Key: 107858554
• Report Number: 2648035-2018-00685
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180726(10)CC09074
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/26/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC09074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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
• Patient Outcome(s): Other