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

Model Number 1MTEC30

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

Section :a5: unknown; requested but not provided.Section b3: date of event: unknown; requested but not provided.Section d6a if explanted; give date: not applicable as the cartridge is not an implantable device.Section d6b if explanted; give date: not applicable as the cartridge is not an implantable device.Section d4: lot number: unknown, information was requested but not provided.Section d4: expiration date: unknown, as the lot number was not provided.Section d4: unique identifier (udi) number: unknown, as the lot number was not provided.Section h4: device manufacture date: unknown, as the lot number was not provided.Section h3-other (81): 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the non preloaded intraocular lens was wasted.From additional information it was learned that the lens inserter was bent and scratched the lenses.The issue was identified during implantation/application and after implantation/application.The lens was fully inserted and removed and replaced during the same procedure.The issue was due to lens inserter being bent.There was no patient injury.There was no medical/surgical intervention required or planned for future.No other information is available.

• 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: 18773761
• MDR Text Key: 336460848
• Report Number: 3012236936-2024-00455
• Device Sequence Number: 1
• Product Code: KYB
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 1MTEC30
• 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: 01/26/2024
• 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
• Treatment: LENS MODEL ZCB00 S/N:3766902308
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG