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

Model Number DIB00

Device Problem Scratched Material (3020)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4, a5: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as no indication that lens was implanted.Section d6b: if explanted, give date: not applicable, as no indication that lens was implanted, hence not explanted.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.

Event Description

It was reported that after implantation, the doctor noticed a chip on the posterior surface of the intraocular lens (iol).Tried to scrape it off with secondary instrument and felt a noticeable divot.Lens fully inserted.Lens inserted and removed during the same procedure.Procedure successfully completed using the back-up lens.Unknown if with incision enlargement, vitrectomy or if sutures was done.Unknown if with delay in procedure.Directions for use (dfu) followed.No medical attention done.Patient fully recovered.Only ophthalmovisco surgical device (ovd) was used as lubrication.Ovd introduced into the cartridge, from the tip or from the cartridge canopy.0-10 minutes per dfu recommend 3 mins.No other information was provided.

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 lens reveal that the lens was coated in viscoelastic residue.The lens was cleaned revealing damage and scratches on the surface of the lens.No further issues were identified.A customer provided photo was received and evaluated.The photo displays the suspect lens inside the patient's eye; the lens can be observed to be damaged.The complaint issue "cosmetic issues" was identified during product evaluation.The observed "lens damaged" is similar to the reported complaint issue (complaint coding may have been the result of the customer being unfamiliar with coding definitions per (b)(4)).Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation, the complaint issue could not be confirmed to be related to the manufacturing or design process.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noticed that an incorrect verbiage for the sections "d6a and d6b" was inadvertently entered in the text of the section "h11" of the initial mdr report.Also, it was noted that an incorrect device manufacture date (jun 10, 2023) was mistakenly entered in section "h4" of the initial mdr report.In review, it was also noticed that the device evaluation conclusion was not properly worded in the mdr follow up #1; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section h4: device manufacture date: jun 11, 2023 section h11: device evaluation conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 18990639
• MDR Text Key: 338984513
• Report Number: 3012236936-2024-00983
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731752
• UDI-Public: (01)05050474731752(17)260611
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: DIB00U0200
• 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: 06/10/2023
• 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