MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information: age: unknown/not provided.Weight: unknown/not provided.Ethnicity: unknown/not provided.Device lot number: unknown as information was not provided.Catalog number: partial catalog number indicated since lot number was not provided.Expiration date: unknown as product lot number was not provided.Udi number: a complete udi number is unknown as product lot number was 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.Device manufacture date: unknown, as product lot number was not provided.Phone number: (b)(6).The device was not returned for analysis.Therefore, a failure analysis of the device cannot be completed.There was no lot number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Attempts were made to contact the customer requesting additional information regarding the complaint; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a large scratch was noticed on the bottom left of the intraocular lens (iol), near the haptic, as the iol was unfolding post implantation.The surgeon commented that the iol was hard to push forward in the injector.The iol was removed and replaced with a back-up lens.Account provided that the procedure had a five (05) minute delay.However, no medical or surgical intervention was required.The cyclosporine prescription has been identified to be for a condition that is not related to cataract complications or standard of care in iol implantation cases.Patient status post surgery was provided as unknown; however, it was indicated that the patient daily activities were not significantly affected.No further information was provided.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• 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: 13430642
• MDR Text Key: 285666369
• Report Number: 3012236936-2022-00293
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ZCT150 LENS 6250082101,UNKNOWN INJECTOR