MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SYNERGY TORIC II; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW375
Medical Device Problem Codes	Crack (1135); Scratched Material (3020)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable, as lens remains implanted.The device is not returning as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a doctor was implanting an intraocular lens (iol) in the patient's right eye, and the iol was scratched.It appears that the cartridge tip was bent/ giving some resistance when twisting out.Nevertheless, the suspect iol was implanted in patient's eye as scratch is on the outer perimeter.Surgeon is planning to see how patient does, if he can see and will then decide if the surgeon will explant it.No vitrectomy and no sutures, but slightly enlarge the wound to 2.7mm from 2.4mm.Post op week 1 he is doing well, he doesn't see the crack as it is out of his primary visual axis.He is 20/25 and j1.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: mar.16, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: no intraocular lens (iol) was received as part of this return therefore, no product evaluation could be performed on the lens.However, visual inspection under magnification revealed that the handpiece was received with the plunger rod partially advanced.A stress mark that deformed the shape of the cartridge tip was observed, which is out of specification.No further issues were identified.The complaint issue "dc-cartridge tip cracked/damaged" was confirmed; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.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.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the initial report incorrectly coded 4582-no clinical signs, symptoms or conditions.The correct code is as follows.Section h6: incision enlargement, health effect - clinical code 4581 - appropriate clinical signs, symptoms, conditions term / code not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYNERGY TORIC II
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 13595907
• Report Number: 3012236936-2022-00500
• Device Sequence Number: 16627025
• Product Code: MFK
• UDI-Device Identifier: 05050474752740
• UDI-Public: (01)05050474752740(17)250120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/22/2022

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: 01/20/2025
• Device Model Number: DFW375
• Device Catalogue Number: DFW375U055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 08/31/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/26/2022; 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian