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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4, a5 patient information: asked.Information unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is on or before feb 29, 2024.Section d6a, if implanted, give date: asked.Unknown/not provided.Section d6b, if explanted, give date: asked.Unknown/not provided.Section h3-other (81): the device has not been received 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 the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson(jnj) monofocal intraocular lens is being returned due to "patient issues".No further details were provided and the event is being reported conservatively reasoning that this return is an explant based on the unknown patient issues.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 3, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint product was visually inspected under magnification revealing that the lens was stuck in the cartridge and overridden by the plunger rod.Ovd was observed inside the cartridge.The lens module was opened and inspected and no issues were observed.The lens could not be removed from the cartridge without damaging the lens and/ or cartridge.No issues that could cause or contribute to the complaint issues were observed.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 quality deficiency, and the reported issue could not be verified.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: 18975500
• Report Number: 3012236936-2024-00946
• Device Sequence Number: 15113057
• Product Code: HQL
• UDI-Device Identifier: 05050474731707
• UDI-Public: (01)05050474731707(17)260820
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2023
• 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