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

Model Number 1MTEC30

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Age, weight, ethnicity: information not provided/not available.If implanted, give date: not applicable.The cartridge is not an implantable device.If explanted, give date: not applicable.The cartridge is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a little plastic chip inside the cartridge observed during lens implantation into the patient's operative eye.Account's brief description of the event indicated that the cartridge did not break but there was a piece of plastic adhering to the inside of the tip and it touched the patient¿s eye as it was coming out.It was provided that the lens was not affected as it did not suffer any damage and it was not scratched.There was no medical or surgical intervention required.The patient has reportedly fully recovered.No further information has been provided.

Manufacturer Narrative

Age, weight, ethnicity: information not provided/not available.If implanted, give date: not applicable.The cartridge is not an implantable device.If explanted, give date: not applicable.The cartridge is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a little plastic chip inside the cartridge observed during lens implantation into the patient's operative eye.Account's brief description of the event indicated that the cartridge did not break but there was a piece of plastic adhering to the inside of the tip and it touched the patient¿s eye as it was coming out.It was provided that the lens was not affected as it did not suffer any damage and it was not scratched.There was no medical or surgical intervention required.The patient has reportedly fully recovered.No further information has been provided.

Manufacturer Narrative

Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.Should material be returned an evaluation will be performed and if there is any further relevant information a supplemental medwatch will be filed.Manufacturing record evaluation: the manufacturing records for the unfolder were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Returned to manufacturer on: jan.8, 2022.Device evaluation: visual inspection was performed.The complaint issue (dc-foreign material: loose) was confirmed (identified as consistent with a polypropylene and an acrylic species); however, due to the low correlation between the substance and the añasco manufacturing process ftir library it cannot be confirmed to be related to manufacturing, and therefore no product deficiency could be identified.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: 12993854
• MDR Text Key: 285499480
• Report Number: 3012236936-2021-00226
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)220525(10)CJ22207
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

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: 05/25/2022
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CJ22207
• 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: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 03/21/2022
• Supplement Dates FDA Received: 01/07/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• 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