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

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Hyphema (1911); Corneal Endothelial Cell Loss (4806)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 h3-other (81): the device was not returned for evaluation as it was discarded; 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 or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) had a large gouge near the center of the optic and the doctor had to do an iol exchange which resulted in a hyphema and likely endothelial damage.The customer had already disposed of both, the lens and the injector.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: the customer provided photo was evaluated by a post market safety surveillance officer.The pictures show a pseudophakic eye, claimed to be implanted with a tecnis eyhance iol with simplicity delivery system, model dib00.It can be observed a mark (crack like) located at the lens mid periphery with a triangular shape.The root cause of the reported event or its potential clinical impact cannot be determined from a picture assessment.The complaint issue "dc-cosmetic issues" 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.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 18441446
• Report Number: 3012236936-2024-00024
• Device Sequence Number: 7847132
• Product Code: HQL
• UDI-Device Identifier: 05050474731684
• UDI-Public: (01)05050474731684(17)260619
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0165
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown