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

Model Number	DIB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4, a5: unknown/ not provided.Asku.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section e1: email address: unknown/ not provided.Section h3-other (81): the device was not returned for evaluation, as lens 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.An attempt has 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 or Problem Description
It was reported that a posterior capsular opacification (pco)- like film was on the actual lens.The lens was loaded correctly, but again appears more of that cartridge coating is getting on the optic.The lens was hydrated with viscoelastic instead of balanced saline solution (bss) and it did not have the residue.It was noted that the pco - like film was not visible at all when hydrated with viscoelastic.The lens remains implanted.No patient impact post op or negative effects.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: no suspect product was received; however, customer photos were provided and evaluated by a post market safety surveillance officer.The pictures show two eyes being implanted with iols claimed to be tecnis eyhance iols preloaded in the simplicity delivery system (model dib00).In both images a grayish/whitish particle/material can be observed, appearing to be located in the space between the posterior surface of iol optical portion and the anterior surface of the capsular bag.The nature, root cause, and potential clinical impact of the reported issue cannot be determined from a picture assessment.The complaint issue "foreign material - loose" was identified during photo evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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
• Common Device Name: 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: 19021131
• Report Number: 3012236936-2024-01020
• Device Sequence Number: 12760791
• Product Code: HQL
• UDI-Device Identifier: 05050474731707
• UDI-Public: (01)05050474731707(17)260817
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown