MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number ICU

Device Problems Device Difficult to Setup or Prepare (1487); Inaccurate Delivery (2339)

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

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

Pt info: unknown/ not provided.Catalog number : a complete catalog # is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.Implant date : unknown/not provided.Explant date: unknown/not provided.Initial reporter: email address: unknown/not provided.(b)(6).Device manufacture date: unknown.The device is not returning for evaluation as to date it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.The serial number for the device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that doctor felt that there was difficulty for the lens coming out of the injector and this also lead to incorrect placement of the lens.There was an additional surgery done on the (b)(6) 2021 to reposition the lens back into the capsular bag and the surgery was a success.No further information available.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• 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: 13056667
• MDR Text Key: 285848147
• Report Number: 3012236936-2021-00333
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICU
• Device Catalogue Number: UNK-ICU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/21/2021
• 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
• Patient Outcome(s): Required Intervention