MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH SMARTLOAD DELIVERY TECHNOLOGY; INTRAOCULAR LENS

Model Number	GCB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight and ethnicity: information unknown/not provided.If implanted, give date: device not implanted.Therefore, no date available.If explanted, give date: device not implanted.Therefore, not explanted.Initial reporter telephone number: (b)(6).The device has 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 will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was moving with difficulty in the cartridge and when preparing it for the implant it did not work well and a notch was made in the optic.There was no patient involvement reported.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes; returned to manufacturer on:13 december 2021; section h3.Device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned for evaluation.The complaint lens was received in a cartridge tray.The original folding carton, patient stickers, directions for use (dfu), a patient id card, and an implant id card were also received.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that it was received stuck to a cartridge tray, which is consistent with a lens that was handled during loading.The lens was cleaned, and a scratch outside of the optic zone was observed.No product deficiency could be identified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search was performed and there are no nonconformance related to this production order (po).During the record review for this production order, the miq (measurement iol quality) process was also reviewed.The lens was processed and inspected according to established procedures.No deviation was found during processes related to the complaint issue reported.A search revealed that no other complaints were received from this production order.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 and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE IOL WITH SMARTLOAD DELIVERY TECHNOLOGY
• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12566190
• Report Number: 2020664-2021-07601
• Device Sequence Number: 1415694
• Product Code: HQL
• UDI-Device Identifier: 05050474620605
• UDI-Public: (01)05050474620605(17)231025
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 10/25/2023
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2020
• 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
• Patient Sex: Unknown