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

Model Number	PCB00
Medical Device Problem Codes	Scratched Material (3020); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during implantation of the pcb00 intraocular lens (iol) there was a scratch/tear on lens optical belt.There was no prescribed medication, no procedural delay, no suture(s), and no vitrectomy, the incision was enlarged and medical attention was required, details regarding medical attention are unknown.Patient's daily activities are not affected.Patient is temporarily impaired as images are distorted.The pcb00 iol may be explanted.Iol is not available for return as it remains implanted in the patient's eye.No further information is available.
Additional Manufacturer Narrative
Section a-2 patient age and date of birth: unknown/asked information unavailable.Section d-6b date explanted: not applicable, as the iol remains implanted.Section e-1 reporter telephone number: unknown, as information was not provided.Section h3-81: the device was not returned for evaluation as it 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.Section h-6 health effect - impact code: 4625 incision enlargement.Section h-6 health effect - clinical code: 4581 incision enlargement.Attempts were made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 05-dec-2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the suspect handpiece was received.Visual inspection of the suspect handpiece found the plunger rod was fully advanced, and ophthalmic viscosurgical device: viscoelastic (ovd) residue was present.No issues that could contribute to the complaint issue reported were observed.Lens was not received, and no further evaluation was performed.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issue could not be confirmed.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 16850397
• Report Number: 3012236936-2023-01078
• Device Sequence Number: 7555817
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)230824
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 08/24/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White