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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: n/a (not applicable).The intraocular lens was not implanted.If explanted, give date: n/a (not applicable).The intraocular lens was not implanted.Therefore, lens was not explanted.The product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.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 that no other complaints were received for this production order number.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has 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 a partially inserted intraocular lens into a patient's right eye was removed and replaced in the same procedure due to bent/broken haptic.There was a patient contact with the lens.The procedure was completed with the same model and diopter lens.It was indicated that the patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information received confirmed that the lens was not fully inserted.There was no surgical interventions required and no patient injury was reported.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: 04/10/2021.Section d9: returned to manufacturer: yes.Section h3: device evaluated by manufacturer? yes.Device evaluation: the pcb00 product was returned in its original package.Visual inspection using magnification was performed to the returned sample and the plunger and pushrod was observed in advanced position.Residues of viscoelastic material was cartridge.The cartridge tip was observed slightly deformed.The lens was not returned with the device.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 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: 11506543
• Report Number: 2648035-2021-07412
• Device Sequence Number: 2856545
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)221203
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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: 12/03/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/20/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 03/18/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR