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

Model Number DCB00

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section h3: other 81: the device was not returned for evaluation.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 have 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 there was issue in the advancement of the preloaded intraocular lens(iol) due to bent haptic.The issue was observed during handling and before patient contact.No other information is available.

Manufacturer Narrative

Corrected data: in review, it was noticed that the "initial reporter email address" was inadvertently not entered in the initial or follow up mdr report #1; therefore, the information has been captured in this supplemental mdr report as indicated below: section e1: initial reporter email address: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: 03/18/2024 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint simplicity reveal that the lens was stuck in the tip of the cartridge.The cartridge tip was also observed to be damaged.Ophthalmic viscoelastic device (ovd) was not observed to be distributed evenly throughout the cartridge indicating that an insufficient amount of ovd may have contributed to the complaint issues reported.The lens module was opened and no ovd or damage was observed inside.The handpiece was disassembled and no issues that could cause or contribute to the complaint issues were observed.The lens could not be removed from the cartridge.The complaint issue "haptic damaged" and "device advancement issue" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: in review, it was noticed that in the section "g2 " of the initial mdr report, the box (company representative) was inadvertently checked in error which should not have been selected.Also, in review, it was noticed that the following fields were inadvertently entered incorrectly in the initial mdr report.This supplemental mdr is to correct the information.The following fields were updated accordingly: section a2, a4 and a5: not applicable as there was no patient contact.Section d6a: if implanted, give date: not applicable, the lens was not implanted as there was no patient contact.Section d6b: if explanted, give date: not applicable, the lens was not implanted as there was no patient contact.Therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• 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: 18897204
• MDR Text Key: 337636769
• Report Number: 3012236936-2024-00577
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636163
• UDI-Public: (01)05050474636163(17)260312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2023
• 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