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	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown/ not provided.If implanted, give date: as there was no patient contact.If explanted, give date: as there was no patient contact.Device evaluation: since product was not returned, the complaint issue reported could not be verified.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 other 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.
Event or Problem Description
It was reported that an intraocular lens (iol) had a loading issue, bent/broken haptic.There was no patient contact.There was no other information provided.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 2/22/2021 section h3.Device returned to manufacturer? yes device evaluation: visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position residues of lubricating material were observed on cartridge.No damaged was observed to the cartridge.The lens was also observed stuck in cartridge.It was too hard to remove the lens from the cartridge to address the haptic damaged condition reported.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 prepared for a surgical process.The complaint issue reported could not be verified.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.

• 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: 11341322
• Report Number: 2648035-2021-07278
• Device Sequence Number: 3347525
• Product Code: HQL
• UDI-Device Identifier: 05050474558236
• UDI-Public: (01)05050474558236(17)211026
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 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: 10/26/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/17/2021
• 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