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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted, hence not explanted.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that two additional complaints were received from this production order, however, these complaints met the criteria for no further investigation.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no 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 preloaded intraocular lens (iol) was damaged.It was noted that it was already damaged when it was opened up.There was patient contact with the lens.No further information was available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: jul 7, 2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.It was returned in its original packaging with patient notification card, patient identification card, and labels.Upon evaluation of the device all the components were correctly engaged, and pushrod was in a partially advanced position.No assembly error and/or defect related to manufacturing process was observed.Trace of lubricant material can be observed in the cartridge and in the storage zone of the lens.Directions for use (dfu) suggests filling the cartridge with ophthalmo-viscoelastic device (ovd).A piece of lens was stuck at the cartridge tip.The lens was received out of the device broken and with a haptic detached.The reported issue of lens damaged was verified.Due to the condition of the sample returned delivery issue could not be verified, and product quality deficiency could not be determined.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: 11996990
• Report Number: 2648035-2021-07934
• Device Sequence Number: 1100226
• Product Code: HQL
• UDI-Device Identifier: 05050474558021
• UDI-Public: (01)05050474558021(17)210723
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/27/2021

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: 07/23/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR