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

Model Number PCB00

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported that when using the injector to inject the iol, the iol was stuck.Upon further injection, the iol pops out of the cartridge.There was no delay in treatment or other interventions reported.No further information was provided.

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A record review was performed and no product deficiency was identified as the device was released within specification.Based on the information obtained, product malfunction cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints.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.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes.Date returned to manufacturer: mar 28, 2023.Section h3: device returned to manufacturer: yes.Device evaluation: no complaint lens was received for evaluation.Plunger rod issue (bent tip) was observed which suggests excessive force was used during insertion.Excess viscoelastic residue was observed inside the lens staging area which suggests excess ophthalmic viscosurgical device (ovd) was used during loading and insertion.This excess can lead to an undesirable plunger rod and lens engagement during insertion which can lead to issues such as the complaint issues reported (however this was not confirmed in the product return).Conclusion: as per complaint investigation results, the product was released within specifications.Relationship between the device and the reported incident could not be determined.Therefore, there is no indication of a product deficiency or product malfunction.Corrected data: upon further review, it was noted that section h6 was addressed inappropriately in the initial mdr report.Therefore, this supplemental filing is to correct section h6-type of investigation by adding code 4109 and adding the manufacturer narrative related to code 4109 (historical data analysis).The following sections have been updated accordingly: section h6-type of investigation: 4109.Section h10 narrative: a search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 16359144
• MDR Text Key: 309554491
• Report Number: 3012236936-2023-00227
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474804296
• UDI-Public: (01)05050474804296(17)250717
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: PCB00
• Device Catalogue Number: PCB000C200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2022
• 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