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

Model Number ZCB00V

Device Problems Inaccurate Delivery (2339); Operating System Becomes Nonfunctional (2996)

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

Event Type  malfunction  

Manufacturer Narrative

Section a2 and a4: unknown; requested but not provided.Section b3: unknown; requested but not provided.Section d6a: if implanted; give date: unknown; requested but not provided.The lens remains implanted.Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section e1: email address: unknown; requested but not provided.Section e1: telephone number: (b)(6).Section g4: this report is being filed on an international device; tecnis optiblue 1-piece iol, that has a similar device, tecnis 1-piece iol model zcb00 which is distributed in the united states under pma p980040.Section h3-other (81): the device was not returned for evaluation as it remains implanted; 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.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the physician had a strong resistant feeling when the plunger was pushed to implant the intraocular lens (iol), feeling like rocket fire.The iol remains implanted and there was no reported patient injury or health damage.No additional information was provided.

• 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: 16753592
• MDR Text Key: 313438409
• Report Number: 3012236936-2023-00947
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474546615
• UDI-Public: (01)05050474546615(17)271008
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2023

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: ZCB00V
• Device Catalogue Number: ZCB00V0135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian