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

Model Number 1MTEC30

Device Problem Contamination (1120)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Explant date: n/a.The cartridge is not an implantable device; therefore, not explanted.(b)(6).The material has not yet been returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a small sliver of plastic, likely from the cartridge, was injected into the eye along with the lens.The surgeon noticed this after the lens had been implanted but the foreign material was removed.It was learnt that the lens remains implanted.No additional information was provided.

Manufacturer Narrative

Additional information: device evaluation: visual inspection of the returned suspect product under magnification revealed that the alleged foreign material was received inside of a specimen vial.The received sample was sent to eag for (fourier transform infrared spectroscopy) ftir testing.The results from the ftir testing at eag laboratories concluded that the correlation of 0.988 was found to match with the demolding tube used in anasco, puerto rico manufacturing site.The complaint issue of foreign material was confirmed during product evaluation.The demolding tube was evaluated with (subject matter expert) sme to address the complaint issue reported.According to manufacturing procedures, the only silicon tube present during the coated procedure is the one used for the dispensing process in the coaters machine as per mi687 ¿cartridge coating procedure¿, also in the wash and dry process mi769 ¿procedure for washing and drying of cartridges coated with biocoat¿ as well.The silicone tube of the coated machine is p/n 20520033 and p/n d291032 for the wash and dry process are indeed made of silicon material, but these tubes are not manufacture by molding methods.Based in the investigation, it can be determined that the foreign material inside the cartridge did not belong to the cartridge manufacturing process.The manufacturing process contains the controls to identify and discard units with the reported issue.Conclusion: the potential assignable cause is undetermined and the material source as well.Based on the assessment performed by the cartridge process sme, the foreign material received do not belong to the cartridge manufacturing process.The manufacturing process contains the controls to identify and discard units with the reported issue.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: after a review of the file it was noted that the investigation findings and conclusions codes were inadvertently omitted during the submission of the supplemental report under 3012236936-2022-00757 on the (b)(6).Additional information: section h6 - investigation findings: 114 - operational problem identified section h6 - investigation conclusions: 4315 - cause not 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13904468
• MDR Text Key: 297616927
• Report Number: 3012236936-2022-00757
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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