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

Model Number DIB00

Device Problems Device Difficult to Setup or Prepare (1487); Operating System Becomes Nonfunctional (2996); Scratched Material (3020)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that an intraocular lens (iol) was not loaded correctly from manufacturer and there was a dent in the optic.It was noted to occur during surgery on left eye, immediately identified and removed from eye.No patient injury nor medical intervention required.Per surgeon note, the iol was inserted and noted to have a defect in the plunger.Surgeon stated this likely happened during loading/insertion as there was irregular resistance with insertion.This iol was cut into pieces and removed using iol cutters and additional viscoelastics.A second iol was opened.There was no there incision enlargement, no vitrectomy, no sutures done.No patient injury.They used balanced saline solution (bss) at room temperature for lubrication.No photos available but product will be returned.Scrub engages (scrub did the first twist), surgeon advances, with dwell time 0-10 minutes per directions for use (dfu) recommend 3 mins.Followed dfu recommendations.No other information was provided.

Manufacturer Narrative

Section a2, a4, a5: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9.Device available for evaluation? yes.Returned to manufacturer on: apr.8, 2024.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection of the complaint simplicity reveal that the cartridge tip was cracked and damaged.The plunger rod tip was also observed to be damaged.Ovd was observed inside the cartridge indicating that an adequate amount was used.The lens module was opened, and no issues were observed.The handpiece was disassembled and no issues that could cause or contribute to the complaint issues were observed.No lens was returned for evaluation.The complaint issue "plunger rod issue" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issue "cosmetic issues" and "difficult to use" 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.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.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: 18983882
• MDR Text Key: 338746795
• Report Number: 3012236936-2024-00969
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731738
• UDI-Public: (01)05050474731738(17)250822
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0190
• 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: 04/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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