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 #2 of the 2 reported events.A separate report is being submitted for the first 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
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: jan.13, 2022 section h3.Device evaluated manufacturer? yes device evaluation: the complaint preloaded was received inside the original folding carton.The complaint preloaded was received with the lens stuck in the cartridge and with the plunger rod completely overriding the lens.Inspection of the external assembly revealed that the plunger rod tip was damaged.The handpiece was disassembled and the assembly was inspected, presenting with no assembly issues.However, during disassembly it was observed that the plunger rod could not be removed from the cartridge without damaging the cartridge and lens.The lens was inspected from the outside of the cartridge and the trailing haptic was found to not be folded and to have haptic damage (bent).No further product evaluation could be performed on the lens.The complaint issue, damage/broken, could not be confirmed.The complaint issue, haptic damage, could be confirmed; however, this may be attributed to excessive force, suggested by the plunger rod tip damage and the fact that the lens was overridden, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.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: 12637192
• Report Number: 2020664-2021-07774
• Device Sequence Number: 4380110
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)230910
• 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
• Report Date (Section B): 03/05/2022

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: 09/10/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• 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: 11/02/2021; 03/02/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/24/2021; 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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