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

Model Number	DIB00
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, a5, a6: unknown/ asked but not available.Section b3: date of event: unknown, information not provided.Section d6a: if implanted, give date: unknown/not provided.Section d6b: if explanted, give date: unknown/not provided.Device evaluation: visual inspection was performed on the suspect lens and found the folding carton was received with a brown stain on the label and folding carton.The folding carton was opened for evaluation and found the sterilization pouch was sealed and showed no staining.The handpiece was seated correctly in the handpiece tray.The lens was inspected through the lens module and appeared to have no issues.No additional issues were identified.No further evaluation was performed.Based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It is reported that the preloaded monofocal intraocular lens (iol), a dib00 30.0, appeared to be damaged with something spilled on it and dried.There was no patient contact.Further information suggests that it looked like a can of soda was spilled on the lens.Additionally, the outer shipping box appeared to have been repackaged.No further information was provided.
Additional Manufacturer Narrative
Upon further review file assess as not reportable as the lens box was spilled/sticky substance (not the inner contents); therefore, no sterility breach.Hence file is no longer reportable.Therefore, this event is assessed as not reportable.There will no longer be any further reporting under mfr report number 3012236936-2024-0002113.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19986812
• Report Number: 3012236936-2024-000211
• Device Sequence Number: 14534342
• Product Code: HQL
• UDI-Device Identifier: 05050474731967
• UDI-Public: (01)05050474731967(17)270617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown