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

Model Number 1MTEC30

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

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

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.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was stuck in the cartridge, the cartridge was cracked, and the cartridge tip was cracked.These issues were noticed while inserting the iol into the eye.A replacement iol was successfully used to complete the treatment.There was no reported patient injury.No additional information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 5/31/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint cartridge was received inside of the original folding carton.Visual inspection under magnification revealed that the cartridge was received with the inside of the cartridge coated in viscoelastic residue.The cartridge tip was observed to be cracked, in a way consistent with a cartridge that was used for implantation.No further issues could be identified and no issues that could contribute to the lens getting stuck could be identified.Visual inspection of the iol revealed that the lens was received with both haptics stuck to the optic body of the lens and coated in viscoelastic residue.The lens was cleaned and the haptics came unfolded.Scratches on the optic body were identified.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 & 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: 14479808
• MDR Text Key: 300354927
• Report Number: 3012236936-2022-01339
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)230127(10)CK04093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

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: 01/27/2023
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CK04093
• 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: 05/09/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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: ZCB00 IOL, SERIAL: (B)(6)
• Patient Age: 78 YR
• Patient Sex: Male