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

Model Number	ZKB00
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, not provided.Implant date: if implanted, give date: not applicable, as lens was not implanted.Explant date: if explanted, give date: not applicable, as lens was not implanted.Hence, not explanted.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a zkb00 intraocular lens (iol) was fully inserted in the left eye (os) when they noticed that the haptic was torn.The procedure was successfully completed with a backup lens.There was no injury, no surgical or medical intervention.No further information provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned as it was destroyed.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that two (02) additional complaints have been received for this production order (po).These complaint issues reported were unable to be confirmed; therefore, no escalations are required.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: 7/22/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.And that the lens was received cut in half and a haptic detached.Which is consistent with a lens, that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.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.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted in the right eye (od) but was explanted due to lens not compatible with the patient.There was no incision enlargement, no vitrectomy, no sutures done.Iol was replaced with a non-johnson and johnson iol.There was no patient post-op injury, patient doing ok.No further information provided.
Additional Manufacturer Narrative
Corrected data: upon review it was determined the event information provided in the initial mdr belonged to a different suspect product, however product identifiers provided in the initial mdr are correct.Therefore, the following impacted fields have been updated to reflect the correct event information.Section a2: date of birth: (b)(6) 1952.Section b1: report type: adverse event.Section b2: outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage.Section b3: date of event: unknown, not provided.Best estimate of date of event is between 12/16/2020 and 3/3/2021.Section b5: it was reported that an intraocular lens (iol) was implanted in the right eye (od) but was explanted due to lens not compatible with the patient.There was no incision enlargement, no vitrectomy, no sutures done.Iol was replaced with a non-johnson and johnson iol.There was no patient post-op injury, patient doing ok.No further information provided.Section d6a: if implanted, give date: (b)(6) 2020.Section d6b: if explanted, give date: (b)(6) 2021.Section e1: complaint reporter first name: steven section e1: complaint reporter last name: lee section h3: device evaluated by manufacturer: no, device evaluation anticipated.Section h6: health effect impact code: 4629: explant.Section h6: health effect clinical code: 2330: dissatisfied.Section h6: medical device problem code: 2993: adverse event without identified device or use problem.Section h6: investigation conclusion: 11: conclusion not yet available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11600103
• Report Number: 2648035-2021-07486
• Device Sequence Number: 17024157
• Product Code: MFK
• UDI-Device Identifier: 05050474560123
• UDI-Public: (01)05050474560123(17)240815
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup,Followup
• Report Date (Section B): 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2024
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/04/2021; 08/02/2021; 08/11/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/30/2021; 08/06/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention