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

Model Number	PCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity: information unknown/not provided.Date of event: information unknown/not provided.If implanted, give date: unknown/not provided.It is unknown if the lens was implanted.If explanted, give date: unknown/not provided.It is unknown if the lens was implanted; therefore, it is unknown if explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The account reported one of the haptics was missing on a pre-loaded intraocular lens (iol).No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed because the product was not returned.The reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: there are no discrepancies found during the mrr (manufacturing record review) related to this complaint.The units were released according specification in compliance with the product intended use as required.A search of complaints revealed no additional complaint was received for this production order number.Conclusion: based on the investigation results there is no indication of a product malfunction or quality deficiency.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: 11943547
• Report Number: 2648035-2021-07964
• Device Sequence Number: 3958934
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)231022
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 10/22/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1