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	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: the lens was not implanted.If explanted, give date: the lens was not implanted; therefore, it was not explanted.Device evaluation: the product was not returned.Therefore, the sample evaluation could not be performed, and the reported issue could not be verified.No product deficiency 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 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 an intraocular lens (iol) was defective.It was from a preloaded product.Provisc used did not have contact with patient.Surgery was completed with another lens.Apparently, the defect was not specifically known by the contact person when follow-up was done.No other information was provided.

• 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: 11520168
• Report Number: 2648035-2021-07424
• Device Sequence Number: 19884661
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)231024
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 10/24/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1