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 Patient Involvement (2645)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity: unknown/ not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Device evaluation: product testing could not be performed since the product was not returned for evaluation.If product be received regarding this event the case will be reopened to complete product evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.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 additional 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic broke off lens when attempting to advance the lens using a preloaded device.However, the customer confirmed that haptic was not detached.There was no patient contact.No other information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/23/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: complaint product was received.It was returned in its original packaging.Also, the implant notification card, some label stickers and direction for use were received.Upon evaluation all the components were correctly engaged.No assembly and/or defect related to manufacturing process was identified.The plunger was in a partially advance position.Traces of lubricating material was observed in the device.The lens got stuck at the cartridge tube, one of the leading haptic was exposed out of the cartridge tip but no damaged was observed.Due to the position of the lens inside the device it is not possible to determine if the other haptic is damaged.Therefore, the reported issue could not be verified.Based in the analysis product quality deficiency could not be determined.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
• MDR Report Key: 11143983
• Report Number: 2648035-2021-07042
• Device Sequence Number: 16301554
• Product Code: HQL
• UDI-Device Identifier: 05050474558090
• UDI-Public: (01)05050474558090(17)230304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 03/04/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1