MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable.If explanted, give date: not applicable.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon experienced issues with platinum 1mte30 cartridge.The packaging was damaged, cartridge was not sterile.The inner pouch seal was incomplete.No patient involvement was reported.Through follow up it was learnt that 6 cartridges were involved.No additional information was provided.Separate reports are submitted to report other suspect cartridges.

Manufacturer Narrative

Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 21 may 2021 section h3.Device evaluated by manufacturer? yes device evaluation: evaluation was conducted on photos provided and returned product.The pictures show two opened outer trays.The outer trays were observed melted.No damaged was observed to the cartridges.It was observed that the seal area for each outer tray was not covered completely.Based in the photos evaluation the reported issue was verified.Samples were received on 21 may 2021, eleven imtec30 cartridges trays were returned for evaluation.Amo puerto rico manufacturing / johnson and johnson surgical vision.Six cartridges trays returned unopened, and five cartridges trays returned opened.Cartridges trays looks like melted.The complaint issue reported was verified.However, escalation is not needed since fi0000042 was previously opened for the same lot number and complaint.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.There are no discrepancies found during the mrr (manufacturing record review) related to this complaint.The units were released according specification in compliance with the product intended use as required.A search revealed that 2 additional complaints were received from this production order.The condition reported for these complaint folders are related to the complaint issue reported.Conclusion: based on the manufacturing controls in-place, manufacturing process record (po) review, sealing process parameters, the sterilization cycle documentation review and the jjsv warehouse temperature log review, the reported complaint cannot be confirmed as cartridge manufacturing process related.Possible assignable cause is mother nature and could be related to shipping or transit.In addition, dc (distribution center ) performed an investigation to address the complaint issue reported, no deviations were found related to this complaint.There is no record of temperature excursion in the dc during the preparation of these orders.The cause could not be established all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11865479
• MDR Text Key: 264142203
• Report Number: 2648035-2021-07818
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)210421(10)CH06526
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CH06526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1