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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight and ethnicity: information unknown not provided.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.Initial reporter first name: unknown not provided.Initial reporter telephone number: unknown/not provided.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that two intraocular lenses were left by a visiting company used by the (b)(6) so description of incident was written on the lens box.One is described simply as broken.The other says broken and problem with haptic.Through follow-ups, it is unclear which lens was described as problem with haptic in addition to being described as broken.No patient injury was reported.Therefore, despite several attempts to collect additional information, no further information is available.This report is for #1 of the 2 reported events.A separate report is being submitted for the second product.
Additional Manufacturer Narrative
Device evaluation: product evaluation could not be performed since at the time of this investigation, the product had not been received.If the product is returned regarding this event the case will be reopened to complete sample evaluation.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.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.
Additional Manufacturer Narrative
Corrected data: upon further review it was discovered a corrected serial number should have been included in the first follow-up report submitted.The following fields were updated accordingly.Section d4: serial number: (b)(4).Section d4: unique identifier (udi) number: (b)(6).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.Returned to manufacturer on: 17 december 2021.Device evaluation: the complaint preloaded was received in a plastic bag.Visual inspection under magnification revealed trace amounts of viscoelastic residue inside of the cartridge.Further observation revealed a lens was stuck inside of the cartridge and had been overridden by the plunger rod.The handpiece was disassembled and the assembly was inspected, presenting with no assembly issues.The lens could not be evaluated because the plunger rod overriding the lens could not be removed from the cartridge without further damaging the lens.Trace amounts of viscoelastic residue was observed in the cartridge which suggests an inadequate amount of ovd was used during loading and insertion which may contribute to deployment issues (including the defects listed in this evaluation).The complaint issues could not be confirmed, and no product deficiency could be determined.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12637179
• Report Number: 2020664-2021-07776
• Device Sequence Number: 14547887
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)240324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 03/02/2022

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: 03/24/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 11/01/2021; 12/07/2021; 02/11/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/10/2021; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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