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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown/ not provided.Implant date and explant date: lens was implanted and then removed on (b)(6) 2021.But patient had to come back the following day to have the replacement ((b)(6) 2021) iol implanted.Complaint reporter last name: unknown/not provided.Reporter telephone: (b)(6).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer partially inserted an intraocular lens (iol) on patient's right eye (od) when the physician noticed one of its haptics was broken and could not be fully implanted.Lens was removed on the same procedure.Medication was prescribed.Patient was temporarily injured and daily activities was affected.The patient had already used the product before.The patient needed to return the day after to put in another lens.The customer understand patient had his activities affected.Nothing with a high level of concern, or that could bring any distress.The medication prescribed was part of the post operative routine.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr, it was noticed that section h6: health effect - impact code 4629 was addressed inappropriately and section h6: medical device problem code: 2339 was inadvertently not included.Therefore, this supplemental filing is to correct the comments initially entered and not included.The following sections have been updated accordingly: section h6: health effect - impact code: 2199 section h6: medical device problem code: 2339 device evaluation: product evaluation was not performed because the product has not been returned.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.

• Brand Name: SENSAR 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: 12124787
• Report Number: 2648035-2021-08099
• Device Sequence Number: 3712799
• Product Code: HQL
• UDI-Device Identifier: 05050474502154
• UDI-Public: (01)05050474502154(17)250921
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 09/21/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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