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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity: unknown/ not provided.If implanted, give date: not applicable, lens was not implanted.If explanted, give date: not applicable, lens was not implanted.Reporter email address: unknown/not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported there was a problem with the injector of a preloaded product.The intraocular lens (iol) was defective, but it did not touch the patient's eye.No other information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: 6/14/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the product returned was received containing the pcb00 device, original folding carton, labels, implant notification and patient id.After the visual evaluation performed the following are the observations: the iol was stuck in cartridge, there was viscoelastic resides only at the cartridge tip.The plunger and push rod were not observed, in advanced position.And locked as direction for use required.The complaint issue reported as defective could not be verified.The condition in which the sample was returned is consistent with a product that was handled and prepared for a surgical process.No product quality deficiency was identified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that the product was manufactured and released according to specifications.A search revealed, one (1) additional investigation "improperly loaded", is not related to the complaint issue reported.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.

• 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: 11891809
• Report Number: 2648035-2021-07886
• Device Sequence Number: 1390021
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)210912
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2021

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: 09/12/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR