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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: information cannot be provided due to personal data privacy legislation/policy.Section a-3a patient sex: information cannot be provided due to personal data privacy legislation/policy.Section a-3b patient gender: information cannot be provided due to personal data privacy legislation/policy.Section a-4 patient weight: information cannot be provided due to personal data privacy legislation/policy.Section a-5 patient ethnicity: information cannot be provided due to personal data privacy legislation/policy.Section a-6 patient race: information cannot be provided due to personal data privacy legislation/policy.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.An attempt was made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
After the pre-loaded dib00 model intraocular lens (iol) was fully inserted in the patient¿s ocular sinister (left eye) a vitrectomy was required, it was also reported the iol was damaged.The iol was removed and there was no incision enlargement, no medical attention, no procedural delays, and no sutures during the initial procedure.It is unknown if medication was prescribed and unknown if another iol was implanted.Patient's daily activities were not significantly affected.The iol directions for use were followed.Patient information cannot be provided due to personal data privacy legislation/policy.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes section d-9: device date returned to manufacturer: 03-apr-2025 section h-3: device evaluated by manufacturer: yes device evaluation: the complaint handpiece was received loose inside a biohazard bag.A lens was also received loose on a piece of medical foam.During a visual inspection, the device was inspected under magnification.The complaint handpiece was received with the plunger rod fully advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge; no cartridge tip or cartridge issues were observed.The lens module was inspected revealing no issues.Device assembly was inspected revealing no issues.Plunger rod advancement was inspected revealing no issues; the plunger rod tip was bent.The lens was received coated in viscoelastic residue and cut in half with one lens half missing.The lens was cleaned revealing the lens was scratched; one haptic was observed to be chipped.No further evaluation was performed.The complaint issue "lens damage" was not identified during photo and product evaluation.Based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was 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: 21370461
• Report Number: 3012236936-2025-000042
• Device Sequence Number: 8564009
• Product Code: HQL
• UDI-Device Identifier: 05050474731776
• UDI-Public: (01)05050474731776(17)270924
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/09/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0210
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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