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 Patient Involvement (2645)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: the cartridge is not an implantable device.If explanted; give date: the cartridge is not an implantable device; therefore, not explanted.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that 3 boxes of 1mtec30 cartridges out of 4 had an issue with the tyvek tray, film being curled and desterilized.The issue was noted upon opening of the packaging.Out of 3 boxes it is unknown how many devices have the reported issue.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

Corrected data in review of section e in follow-up 1, the country was inadvertently selected as united states, however, the country should have been france.Additional information received.The report was reviewed the customer received a product from rhenus logistics.Rhenus logistics is temperature controlled facility, where johnson & johnson surgical vision (jjsv) products are kept under strict temperature range and could have not been subjected to high temperatures.Rhenus team was contacted to investigate this issue, a picture was requested of the box of product, however there is no further stock of this product at the facility.The transport of the devices from rhenus to the customers was not temperature controlled.However, the transport of those products occurred in winter season and short distances.It is unlikely that those products were subject to high temperatures from rhenus to the customers in the conditions described.A checked of our complaint database to verify if the emea3pls have reported any issues that match the description of the issues registered in this complaint.One nonconformance that matches the description was identified (# nr-0147385).As per investigation, the products were shipped to rhenus in summer months and this could potentially be the root cause of this issue.In conclusion, do not have evidence that this issue was originated in rhenus as the warehouse is temperature controlled and the transport of those products was a short distance in winter season.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: no product evaluation was performed since no product received.Based on the photo provided as part of the complaint cp-0003073, the units do not meet the visual inspection requirements included in qi5003 ¿packaging and boxing inspection for cartridges¿ rev.26.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.  a search revealed that one additional complaint for this order number have been received.Conclusion: based on the manufacturing controls in-place, manufacturing process record, review, sealing process parameters and the sterilization cycle documentation review performed, 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.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
• MDR Report Key: 11144216
• MDR Text Key: 228171857
• Report Number: 2648035-2021-07053
• 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,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1