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

Model Number DCB00V

Device Problems Mechanical Jam (2983); Scratched Material (3020)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4, a5: unknown/asked but not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown, as information was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted; give date: not applicable, there is no indication the lens has been explanted.Section e1: telephone number:(b)(6).Section h3-other (81): the device was not returned for evaluation as it was discarded; 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.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain missing information.However, there is no additional information available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a surgeon was having difficulties inserting the preloaded monofocal intraocular lens (iol) into the patient's operative eye.It was reported as sticking injector, causing marks/dents on the lens itself; sometimes unable to inject at all.The iol is not available.No further information was available.This report is to capture the product problem number 2.A separate report is being submitted to capture the product problem number 1 for this model.

• Brand Name: TECNIS SIMPLICITY
• 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: 19076810
• MDR Text Key: 340600095
• Report Number: 3012236936-2024-00965
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• 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: 04/09/2024

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 Model Number: DCB00V
• Device Catalogue Number: UNK-DCB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/09/2024
• 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