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

Model Number 1MTEC30

Device Problems Crack (1135); Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Weight, and ethnicity: unknown, information not provided.Date implanted: not applicable, as the cartridge is not an implantable device.Date explanted: not applicable, as the cartridge is not an implantable device.Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported during the surgical procedure of phacoemulsification and intraocular lens (iol) that as the iol was assembled in the 1mtec30 cartridge, at the moment of lowering the injector pocket the iol got stuck in the cartridge, an attempt to lower where the pocket passes over the lens.It was not possible to advance the lens, the lens is carefully removed from the 1mtec30 cartridge and by order of doctor the lens was re-assembled in an alcon cartridge.The lens was mounted correctly and successfully implanted in good condition.Through follow-up information was received confirming the cartridge tip had patient contact.There was no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.The lens was successfully implanted in the anterior chamber in good condition.Additional information was received confirming cartridge tip was damaged and the tip of the injector plunger goes over the lens and hit the tip of the cartridge.No other information was provided.

Manufacturer Narrative

Additional information: section h-3 device evaluated by manufacturer: yes device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received.If the product is returned regarding this evaluation the case will be reopened to complete sample evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.During the record review no nonconformity report was revealed related to this production order/complaint issue reported.Historical data analysis: a search of complaints revealed that four (04) additional complaint folders were found as part of this production order (po) number.No product malfunction or deficiency could be identified, and no escalation was required in those cases.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Attempts were made to contact the customer account requesting additional information regarding iol serial number and handpiece information however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional info: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 18-feb-2022.Device evaluation: the complaint cartridge received inside of the cartridge tray.Visual inspection under magnification revealed that the the cartridge was received without a lens inside of it.The cartridge tip was inspected, presenting with stretch mars within the tip however, the marks were within acceptable parameters.No iol was received as part of this return therefore, no product evaluation could be performed on the lens.The complaint issues could not be confirmed, and no product deficiency could be identified.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & 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 ; 1700 e. st. andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12577255
• MDR Text Key: 274816999
• Report Number: 2020664-2021-07574
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)220202(10)CJ13725
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CJ13725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female