MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problem Crack (1135)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported that after implantation of an intraocular lens (iol), the surgeon noticed that the tip of the cartridge was defective.The lens was prepared and implanted normally.The ophthalmic viscosurgical device (ovd) used was a non-johnson and johnson brand.The eye was cleaned carefully during irrigation/aspiration.There were no signs of any plastic pieces in the eye and there was no need to explant the lens.The patient has fully recovered and no further details were provided.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.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.(b)(6).The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device lot history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, 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.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 23rd may 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the complaint cartridges were received inside of the original cartridge trays.Product evaluation was performed under magnification.Two cartridges of the same lot as this investigation were received.One cartridge presented with no issues.The other cartridge presented with cartridge tip damage.Visual inspection under magnification revealed that the cartridge was received with no issues, in a way consistent with a cartridge that was not used.No issues could be identified with the cartridge or cartridge tip.Visual inspection under magnification revealed that the cartridge was received with viscoelastic residue inside of it.Damage to the cartridge tip was also observed, consistent with a cartridge that was used during implantation of an iol.The customer provided photo of the cartridge also shows the cartridge tip crack.The complaint issue of cartridge tip cracked/damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14108753
• MDR Text Key: 298722935
• Report Number: 3012236936-2022-00990
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)221104(10)CJ32733
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CJ32733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: DISCOVISC