MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU225
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown/no information.If implanted; give date: not applicable.The iol was removed/replaced in the initial surgery.If explanted; give date: not applicable as the iol was removed within the same procedure.Reporter email address: unknown/no information.Manufacturer phone number: (b)(4).Device evaluation: product evaluation was not performed because the product has not yet been received.The complaint issue reported could not be verified and no product deficiency could be identified.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating that the intraocular lens (iol) was partially inserted in the patient¿s left eye but the iol was torn.The partially inserted lens was removed and replaced within the same procedure and replaced with a backup iol of the same model and diopter.The outcome does not significantly interfere with activities of daily life.Reportedly, the patient has recovered.It was confirmed that the product was discarded.No more information is available.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11766575
• Report Number: 9614546-2021-07124
• Device Sequence Number: 4492283
• Product Code: HQL
• UDI-Device Identifier: 05050474658998
• UDI-Public: (01)05050474658998(17)240925
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 09/25/2024
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR