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

Model Number	PCB00
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: unknown/not provided.If explanted; give date: unknown/not provided.Phone : (b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the iol (intraocular lens) was not sterile.It was stated that there was no patient contact.After several follow-ups no further information available.
Additional Manufacturer Narrative
Device evaluation: the product was not returned for evalution.The reported complaint was not confirmed.Manufacturing records review: the manufacturing records for the product 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.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: 11396912
• Report Number: 2648035-2021-07317
• Device Sequence Number: 16987370
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)220610
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 06/10/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1