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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the physician was unable to inject the preloaded intraocular lens as the plunger was on top of the lens instead of behind it.There was damage to the lens due to the issue.There was patient contact with the cartridge tip.There was no harm to the patient and no medical intervention was required.A new lens was opened up for the case.No further information was available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: july 15, 2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using magnification was performed to the returned sample.The plunger and pushrod was observed in advanced position and in good condition.Residues of viscoelastic material were observed on cartridge.No damaged was observed to the cartridge.The lens was observed stuck at the cartridge tip section.It was too hard to remove the lens from the cartridge to address the lens damage condition.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepare for surgical process.The complaint issue reported as lens damaged and override could not be verified.However, the complaint issue reported as stuck in cartridge was verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing process record was evaluated, and no discrepancies were found during the mrr (manufacturing record review) related to this complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed one additional compliant folder for this production order number has been received, however, no product deficiency was identified.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.

• 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: 12148033
• Report Number: 2648035-2021-08110
• Device Sequence Number: 17208381
• Product Code: HQL
• UDI-Device Identifier: 05050474558229
• UDI-Public: (01)05050474558229(17)230922
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 09/22/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR