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

Model Number	DCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an intraocular lens (iol) unfolded in the right eye, it was noted there was a scratch on the optic and needed to be removed in the same procedure.When the lens was cut in half and removed, one of the halves was lost in the drapes.Another johnson & johnson lens (same model and diopter) was successfully implanted as a replacement.A vitrectomy was not required, however, an incision enlargement and sutures were required.There was no patient injury.No other information was provided.
Additional Manufacturer Narrative
Ethnicity/race: unknown/asked but did not provide.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Ifexplanted, give date: not applicable, as lens was removed/replaced during the same procedure.Intal reporter telephone number: +1(403)252-3937 (b)(4).Other 81: the device was not returned for analysis.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, the account did not provide some of the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 20-apr-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received taped to the original simplicity.The original simplicity was received inside of the original folding carton.Visual inspection under magnification revealed that the lens was received cut in half (one half missing), the lens was cleaned, and a scratch was identified on the optic body.A scratch on the haptic was found as well.The handpiece presented with a bent plunger rod tip and a cartridge tip crack.The handpiece was disassembled, and the assembly was inspected, no assembly issues were identified.Cosmetic issue 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.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 confirmed.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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: 14002132
• Report Number: 3012236936-2022-00877
• Device Sequence Number: 14551407
• Product Code: HQL
• UDI-Device Identifier: 05050474636255
• UDI-Public: (01)05050474636255(17)230304
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 03/04/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000285
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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: Female
• Patient Weight: 72 KG