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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight and ethnicity: information unknown not provided.Implant date: if implanted, give date: unknown/not provided.Explant date: if explanted, give date: unknown/not provided.Telephone number: (b)(6).Device evaluation: since product is not available for evaluation, the complaint issue was not verified.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.
Event or Problem Description
It was reported that the cartridge tip cracked when the lens should be injected.The issue was first identified during implantation/application.The cartridge tip was in contact with the eye.It was reported that there was no patient injury.The customer has no further information than what has been provided.
Additional Manufacturer Narrative
Device evaluation: since suspect product is not available for evaluation, the complaint issue was not verified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed, that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain the material.However, to date, no material has been received.All pertinent information available to johnson and 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: 12207985
• Report Number: 2648035-2021-08067
• Device Sequence Number: 16939043
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)240211
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 02/11/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1